Noninvasive Fat Reduction With the CoolSculpting System
Phase: NA
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-305578 
Revision: 04 
Page 1 of 50
Title: Noninvasive Fat Reduction with the CoolSculpting System 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ 
Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
Noninvasive Fat Reduction with the CoolSculpting 
System 
Investigational Plan 
Sponsor 
ZELTIQ Aesthetics, Inc., An Allergan Affiliate 
4410 Rosewood Dr. 
Pleasanton, CA 94588
Protocol Number: 
ZA20-001 
Protocol Version: 
04 
Protocol Date: 
19 September 2022 
Product (s) 
CoolSculpting System 
Sponsor Contact:
 
  
PH: 
 
Email:  
  
NCT #:  NCT04506307

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Revision: 04 
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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-305578 
Revision: 04 
Page 3 of 50
Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ 
Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-305578 
Revision: 04 
Page 4 of 50
Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
 
 
 
 
INVESTIGATOR SIGNATURE PAGE 
 
For protocol number ZA20-001 
 
 
I agree to: 
 
• Implement and conduct this study diligently and in strict compliance with this 
protocol, GCP, and all applicable laws and regulations. 
 
• Maintain all information supplied by the Sponsor, ZELTIQ Aesthetics, an 
Allergan affiliate, in confidence and, when this information is submitted to an 
Institutional Review Board (IRB) or Ethics Committee (EC), or another group, 
it will be submitted with a designation that the material is confidential. 
 
 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
______________________         ______________________         _______ 
Investigator printed name                        Signature  
 
Date 
 
 
______________________         ______________________         _______ 
Investigator printed name                        Signature  
 
Date 
 
 
 
 

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Revision: 04 
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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
 
RETURN PAGE TO SPONSOR 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-305578 
Revision: 04 
Page 6 of 50
Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ 
Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
Table of Contents 
 
1. 
Protocol Summary ......................................................................................... 9 
2. 
Introduction ................................................................................................. 11 
 
Background ................................................................................................... 11 
 
Regulatory Status ........................................................................................... 12 
 
 ..................................................................................... 13 
3. 
Device Description ....................................................................................... 13 
4. 
Study Objectives .......................................................................................... 14 
5. 
Investigational Plan ...................................................................................... 14 
 
Study Design .................................................................................................. 14 
 
Investigator Qualifications ............................................................................. 14 
 
Study Population ............................................................................................ 15 
5.3.1. 
Target Patient Population ............................................................................... 15 
5.3.2. 
Subject Eligibility.............................................................................................. 15 
5.3.3. 
Vulnerable Populations ................................................................................... 16 
6. 
Study Conduct and Procedures ..................................................................... 16 
 
Recruitment ................................................................................................... 16 
 
Informed Consent .......................................................................................... 16 
 
Screening Procedures ..................................................................................... 17 
 
 ..................................................................................................... 18 
 
 ................................................................ 18 
 
Treatment Procedures.................................................................................... 19 
6.6.1. 
Treatment Visit #1; Required; Day 0 ............................................................... 19 
6.6.2. 
Treatment Visit #2; Required; 6 Weeks (± 1 week) ......................................... 20 
 
Follow-up Procedures .................................................................................... 21 
6.7.1. 
One-Week Phone Follow-Up (post-each treatment); Required: 7 Days (± 3 
days) 
21 
6.7.2. 
 ... 21 
6.7.3. 
Twelve-Week Final Follow-up; Required (Day 90 +/- 14 days post-treatment)
 
22 
6.7.4. 
Optional Follow-Up Evaluations (up to 2 within study period) ....................... 22 
 
 ................................................................................................... 24 
6.8.1. 
 .................................................................................................... 24 
6.8.2. 
 .............................................................. 24 

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
6.8.3. 
 ..................................................................................... 25 
6.8.4. 
 .......................................................................... 25 
6.8.5. 
 ......................................................................................... 26 
7. 
Statistical Methodology and Analyses .......................................................... 26 
 
Primary Endpoints ......................................................................................... 26 
 
Statistical Methods: Overall Plan ................................................................... 26 
 
Analysis Cohorts ............................................................................................ 26 
7.3.1. 
Safety Cohort ................................................................................................... 26 
7.3.2. 
Effectiveness Cohorts ...................................................................................... 26 
7.3.3. 
Endpoint Analysis ............................................................................................ 27 
7.3.4. 
Missing Data Handling: .................................................................................... 27 
7.3.5. 
Data Pooling: ................................................................................................... 28 
7.3.6. 
 .................................................................................. 28 
8. 
Adverse Events ............................................................................................ 28 
 
Adverse Device Effect (ADE) ......................................................................... 29 
8.1.1. 
Serious Adverse Device Effect (SADE) ............................................................. 29 
8.1.2. 
Unanticipated Serious Adverse Device Effect (USADE) ................................... 29 
8.1.3. 
Serious Adverse Event (SAE) ............................................................................ 30 
8.1.4. 
Time Period and Frequency for Collecting AE and SAE Information ............... 30 
8.1.5. 
Method of Detecting AEs and SAEs ................................................................. 31 
8.1.6. 
Follow-up of AEs and SAEs .............................................................................. 31 
8.1.7. 
Reportable Incidents ....................................................................................... 31 
8.1.8. 
Assessment of Severity .................................................................................... 32 
8.1.9. 
Assessment of Relatedness ............................................................................. 32 
8.1.10. 
Serious Adverse Event Reporting Procedures ................................................. 35 
8.1.11. 
Pregnancy ........................................................................................................ 36 
9. 
Device Tracking ............................................................................................ 36 
 
Device Packaging and Labeling ...................................................................... 36 
10. 
Device Deficiencies and Malfunctions ....................................................... 37 
11. 
Ethical and Regulatory Considerations ...................................................... 37 
 
Compliance with Good Clinical Practice .................................................... 37 
 
Institutional Review Board (IRB) and Informed Consent ........................... 37 
 
Protocol Adherence .................................................................................... 38 
 
Protocol Amendments ................................................................................ 38 
12. 
Study Management and Quality Control ................................................... 39 

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
 
Study Data Collection ................................................................................. 39 
 
Data Management ...................................................................................... 39 
12.2.1. 
Data Receipt and Data Entry ........................................................................... 39 
 
Confidentiality ............................................................................................ 39 
 
Quality Assurance Audits ........................................................................... 40 
 
Investigator Responsibilities ....................................................................... 40 
12.5.1. 
General Responsibilities .................................................................................. 40 
12.5.2. 
Investigator Records ........................................................................................ 41 
12.5.3. 
Investigator Reports ........................................................................................ 42 
 
Sponsor Responsibilities ............................................................................. 43 
12.6.1. 
General Responsibilities: ................................................................................. 43 
12.6.2. 
Site Monitoring ................................................................................................ 44 
12.6.3. 
Final Report ..................................................................................................... 46 
12.6.4. 
Trial Registration ............................................................................................. 46 
13. 
Data Ownership........................................................................................ 46 
14. 
 ..................................................................................... 46 
15. 
 ................................................................................ 46 
 
 ....................................................................................................... 46 
 
 ........................................................................................................... 47 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-305578 
Revision: 04 
Page 9 of 50
Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ 
Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
1. Protocol Summary 
Title 
Noninvasive Fat Reduction with the CoolSculpting System 
Design 
Prospective, open-label interventional study 
Objective/Purpose 
Evaluate the safety and efficacy of multiple, simultaneous 
CoolSculpting cycles for the purpose of non-invasive fat 
reduction 
Enrollment 
Up to 60 subjects 
Clinical Sites 
Up to 6 investigational sites 
Participant/ 
Subject population 
 
Healthy adult men and women aged 22 – 65 who desire 
non-invasive fat reduction in the torso 
Treatment 
Upon qualification, each subject will receive 2 treatment 
sessions, 6 weeks apart with the CoolSculpting System. At 
each treatment visit, multiple simultaneous cooling cycles 
will be performed on areas of the torso (abdomen, flanks 
and/or back) identified for fat reduction using 
CoolSculpting System applicators. A minimum of 8 (eight) 
cooling cycles will be performed throughout the 
evaluation.  Follow-up visits are scheduled at 4 weeks and 
12 weeks post-final treatment; phone follow-up will occur 
1week after each treatment visit. 
Primary Endpoint(s) 
Safety endpoint: The frequency of device and procedure-
related adverse events (AEs), including device-related 
serious adverse events (SADEs), will be summarized. 
   
Efficacy endpoint: Correct identification of pre-treatment 
vs. 12-week post-treatment images by at least two out of 
three blinded, independent reviewers. Success will be 

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
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defined as at least 70% correct identification of the pre-
treatment images.  
Sponsor 
ZELTIQ Aesthetics, Inc., An Allergan Affiliate  
4410 Rosewood Dr. 
Pleasanton, CA 94588

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
2. Introduction  
 Background 
Fat reduction and body contouring procedures, which include invasive, 
minimally-invasive, and non-invasive procedures, have become increasingly 
popular aesthetic procedures. Patients who are obese and do not have specific fat 
bulges but require significant fat reduction to achieve aesthetic results are 
candidates for invasive and minimally-invasive procedures, such as liposuction 
and laser-assisted liposuction. Although effective at reducing fat, these invasive 
and minimally-invasive procedures involve significant patient discomfort, 
expense, downtime, and the risks typically associated with surgical procedures. 
As a result, patients who do not require significant fat reduction to achieve 
meaningful aesthetic results typically seek non-invasive fat reduction and body 
contouring procedures to avoid the pain, expense, downtime, and surgical risks 
associated with invasive and minimally-invasive procedures. 
ZELTIQ Aesthetics has developed and commercialized a technology for cold-
assisted lipolysis.  The ZELTIQ CoolSculpting technology is based on the 
sensitivity of fat cells to cold injury in order to selectively eliminate subcutaneous 
fat tissue without affecting the skin or other surrounding tissues. The technology, 
cryolipolysis, enables a non-invasive alternative for subcutaneous fat reduction 
through cellular apoptosis. The ZELTIQ CoolSculpting System is cleared for use 
in the United States for the indication of cold-assisted lipolysis of various body 
areas, including the upper arm, bra fat, back fat, banana roll, thigh, abdomen, and 
flank in individuals with a body mass index (BMI) of 30 or less. In addition, the 
device is intended for cold-assisted lipolysis of the submental and submandibular 
areas in individuals with a BMI up to 46.2. The CoolSculpting System has been 
clinically proven to reduce fat bulges, allowing patients to achieve noticeable and 
measurable aesthetic results without the pain, expense, downtime, and risks 
associated with existing invasive and minimally-invasive procedures.  
 
Clinical studies of the CoolSculpting System used on the abdomen have 
demonstrated the treatment to be safe and effective for the reduction of 
subcutaneous fat. Subjects in a recent study rated their satisfaction with the 

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
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CoolSculpting procedure at 73% and 89% indicated they would recommend the 
procedure. 1 
 
While the CoolSculpting procedure is successful in reducing subcutaneous fat in 
various anatomical areas, patients often desire treatment in multiple body areas 
(e.g. abdomen and flanks) necessitating serial treatment sessions to achieve 
desired results.  Physician feedback suggests patients would prefer to have 
multiple CoolSculpting cycles performed at once in a single office visit to reduce 
the overall time of the procedures.  ZELTIQ is exploring the simultaneous use of 
multiple CoolSculpting applicators to reduce overall treatment time and improve 
body contouring effects for multiple body areas.  
Zeltiq has enhanced the CoolSculpting System to accommodate simultaneous use 
of two applicators.  The new system, the CoolSculpting Elite System, is under 
investigation in this evaluation.   The purpose of this trial is to further evaluate the 
safety and efficacy of the CoolSculpting Elite System when multiple cooling 
cycles are applied simultaneously to the torso for non-invasive subcutaneous fat 
reduction. 
 Regulatory Status  
The CoolSculpting System has been cleared in the United States for use as an 
aesthetic treatment to affect the appearance of the flanks (DEN090002), abdomen 
(K120023), thighs (K133212), arms (K162050), submental area, (K181740) 
submandibular area (K151179), and bra fat, back fat, and banana roll (K160259). 
Additionally, the System has been cleared for flexible treatment parameter ranges 
(K142491). FDA clearance allows treatment duration of up to 120 minutes, and at 
temperatures as low as -15°C.  
 
 
 
 
1 Krueger, N., Mai, S. V., Luebberding, S., & Sadick, N. S. (2014). Cryolipolysis for   
noninvasive body contouring: clinical efficacy and patient satisfaction. Clinical, cosmetic 
and investigational dermatology, 7, 201.  
 
 

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
The device was also previously cleared for cooling as a method to minimize 
localized pain and thermal injury during laser and dermatological treatments 
under: K060407 (initial clearance), K063715 (clearance for warming and 
massage), K072152 (clearance for flat and belt applicators), K080118 (clearance 
for vacuum applicator), and K090094 (clearance for commercial device) and 
K193566 (clearance for updated CoolSculpting System). 
 
3. Device Description 
The CoolSculpting Elite System is comprised of a control unit (Figure 1) which 
houses the system controller and power source, and two detachable applicators 
that are used to apply the cooling and/or warming to the treatment site. The 
applicators use vacuum pressure to draw tissue into the cup shaped applicator. 
The applicator types to be used in this study are the CoolSculpting family of 
applicators. (Figure 2).  Physicians will select an appropriately sized applicator 
for the body area(s) intended for treatment.  All applicators will be used with 
cooling cycle parameters of a temperature of -11°C, and treatment duration of 35 
minutes or 45 minutes (as appropriate by applicator type).   
  

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
without prior written consent of ZELTIQ. 
 
 
 
4. Study Objectives 
The objectives of the trial are to determine the safety and effectiveness of 
performing multiple simultaneous cooling cycles on the torso with the 
CoolSculpting Elite System.  
5. Investigational Plan 
Upon qualification, each subject will receive 2 treatments sessions 6 weeks apart 
with the CoolSculpting Elite system. At each treatment visit, multiple 
simultaneous cooling cycles will be performed on areas of the torso (abdomen, 
flanks and/or back) identified for fat reduction using CoolSculpting System 
applicators. A minimum of 8 (eight) cooling cycles will be performed throughout 
the study.  Follow-up visits are scheduled at 4 weeks after each treatment visit and 
12 weeks post-final treatment; phone follow-up will occur 1week after each 
treatment visit.  
 Study Design 
Up to 6 sites will enroll 60 eligible subjects in this prospective, interventional, 
non-randomized open-label study.  Enrollment and follow-up is expected to take 
up to five (5) months for each subject.  The completion time for enrollment is 
anticipated to be 5 months, with the total study duration expected to be 
approximately 10 months. 
 Investigator Qualifications  
To participate in this study, an Investigator must have an active medical license 
and board certification in dermatology and/or plastic surgery.  The investigator 
must undergo training on the study device(s) prior to study initiation. 

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Title: Noninvasive Fat Reduction with the CoolSculpting System 
 
ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
(OneV-83717 Ver 2.0) 
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Site investigators must have at least one study coordinator with experience in 
conducting aesthetic research and with sufficient time to conduct the study. 
 Study Population 
5.3.1. 
Target Patient Population 
Patients who seek non-invasive fat reduction in the torso region 
(abdomen, flanks, bra fat, and/or back fat) will be recruited for 
this study.  
5.3.2. 
Subject Eligibility 
To be included in the study, potential subjects must meet all of the 
inclusion criteria and none of the exclusion criteria listed below. 
Inclusion Criteria 
a) Subject (healthy volunteer) has read and signed the study written 
informed consent form.  
b) Male or female ≥ 22 years and ≤65 years of age.  
c) Subject has clearly visible fat in one or more areas on the torso 
(abdomen, flank, back fat, bra fat), which in the investigator’s opinion, 
may benefit from the treatment.  
d) Subject has not had weight change exceeding 5% of body weight in the 
preceding month.  
e) Subject agrees to maintain his/her weight (i.e., within 5%) by not 
making any major changes in their diet or exercise routine during the 
study.  
f) Subject has a BMI ≤ 30 as determined at screening.  
g) Subject agrees to have photographs taken of the treatment area(s) during 
the scheduled time periods.  
Exclusion Criteria 
a) Subject has had a recent surgical procedure in the area of intended 
treatment. 
b) Subject has had an invasive fat reduction procedure (e.g., liposuction, 
mesotherapy) in the area of intended treatment.  
c) Subject has had a non-invasive fat reduction and/or body contouring 
procedure in the area of intended treatment within the past 12 months.  
d) Subject needs to administer or has a known history of subcutaneous 
injections into the area of intended treatment (e.g., heparin, insulin) 
within the past month.  
e) Subject has a known history of cryoglobulinemia, paroxysmal cold 
hemoglobinuria, or cold agglutinin disease. 

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ZELTIQ P/N: CS-305578-04 
Protocol Number: ZA20-001 
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f) Subject has a known sensitivity to cold, such as cold urticaria, 
Raynaud’s disease, chilblains (pernio), or any known condition with a 
response to cold exposure that limits blood flow to the skin.  
g) Subject has a history of bleeding disorder or is taking any medication 
that in the investigator’s opinion may increase the subject’s risk of 
bruising.  
h) Subject is taking or has taken diet pills or supplements within the past 
month.  
i) Subject has any dermatological conditions, such as moderate to 
excessive skin laxity, or scars in the location of the treatment sites that 
may interfere with the treatment or evaluation (stretch marks is not an 
exclusion).  
j) Subject has an active implanted device such as a pacemaker, 
defibrillator, or drug delivery system  
k) Subject has a history of hernia in the area(s) to be treated.  
l) Subject is pregnant or intending to become pregnant during the study 
period (in the next 8 months).  
m) Subject is lactating or has been lactating in the past 6 months.  
n) Subject is unable or unwilling to comply with the study requirements.  
o) Subject is currently enrolled in a clinical study of any unapproved 
investigational drug or device.  
p) Any other condition or laboratory value that would, in the professional 
opinion of the investigator, potentially affect the subject’s response or 
the integrity of the data or would pose an unacceptable risk to the 
subject.
5.3.3. 
Vulnerable Populations 
Children, pregnant women, fetuses, neonates and prisoners are not 
included in this study. 
6. Study Conduct and Procedures 
 Recruitment 
Potential study subjects will be recruited from clinics of participating 
investigators as well as through local advertising.  Any study-related 
advertisements will be approved by the governing IRB/EC prior to use.   
 Informed Consent 
Subjects will be recruited from the Investigator’s clinical practice and via IRB/EC 
approved advertising.  Once the patient’s potential eligibility has been 

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ZELTIQ P/N: CS-305578-04 
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determined, the Investigator or designee trained to the protocol will explain the 
nature and scope of the study, risks and benefits of participation, answer questions 
for the subject, and invite the subject to participate.  The study will be explained 
in lay terms.  If the patient agrees to participate, the IRB/EC-approved informed 
consent will be signed and dated by the patient and the Investigator or designee.  
A copy of the signed and dated informed consent will be provided to the study 
subject.  
 Screening Procedures 
After the informed consent is signed, participants will be screened for eligibility.  
Each participant will be interviewed to determine that all selection criteria are 
met.  The Investigator or designee shall complete a medical history and examine 
the participant to confirm eligibility for the study. The following activities will be 
performed at the screening visit: 
1. 
Obtain height and weight. 
2. 
Calculate BMI. BMI is calculated by multiplying subject weight (in 
pounds) by 703 divided by the square of the subject’s height in inches.  
3. 
Assess for any medical conditions that would lead to exclusion of a 
subject from the study. 
4. 
Visually assess and palpate the intended treatment area to determine if 
it is appropriate for treatment.  
5. 
A tissue draw assessment on the treatment sites may be performed to 
verify the potential subject is a good candidate for CoolSculpting in the 
torso region such that a minimum of eight cooling cycles can be 
administered.  
6. 
Document medication use, Fitzpatrick Skin Type, and ethnicity. 
7. 
Schedule pre-treatment photo visit (to be completed up to 30 days prior 
to treatment). 
8. 
All female subjects of childbearing potential will be asked to take a 
pregnancy test (urine) prior to being treated. If the subject is pregnant, 
she will be excluded from participation.  
 
Female participants of childbearing potential will be advised to avoid becoming 
pregnant during the course of the study by using a medically accepted form of 
contraception if they are sexually active.  If the participant becomes pregnant 
during the course of the study, she will not be treated subsequently with the study 

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Aesthetics, Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited 
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device or be required to have follow-up photographs and ultrasounds taken.  
Female participants of childbearing potential will be assessed for the start date of 
their last menstrual cycle.  
All participants will be asked to maintain their weight by not making any major 
changes to their diet or exercise routine during the study.  Participants who do not 
maintain their weight within 5% of their baseline body weight will continue in the 
study but will be excluded from the effectiveness analyses. 
Participants who meet all of the inclusion criteria and none of the exclusion 
criteria shall be eligible to participate in the study and the first treatment will be 
scheduled. 

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 Treatment Procedures 
6.6.1. 
Treatment Visit #1; Required; Day 0  
 
Prior to CoolSculpting Treatment 
1.  Review inclusion and exclusion criteria.  
2. Repeat pregnancy test for female subjects of childbearing potential 
(urine). Exclude subject from participation if the results are positive.  
3. If the subjects meet all of the inclusion criteria and none of the 
exclusion criteria, then proceed with the study treatment.  
4. Obtain weight  
5. Obtain baseline photographs of the torso using standardized setup 
and settings. Alternatively, the baseline photographs may be 
collected at screening visit.  
6. Obtain 3-D images. 
7. Use template to mark the treatment area on each torso area intended 
for treatment.  After marking: 
a. Insert one geltrap into each slot on back of applicator cup.  
 c. Clean the treatment area with an alcohol wipe.  
 
d. Clean the treatment area using a pre-treatment skin wipe.  
 
e. Apply CoolAdhesive GelPad on the treatment area per 
manufacturer’s instructions for use.  
 

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6.6.2. 
Treatment Visit #2; Required; 6 Weeks (± 1 week) 
1. Review Inclusion and Exclusion criteria. 
2. Obtain weight.  
3. Repeat pregnancy test for female subjects of childbearing 
potential (urine). Exclude subject from participation if the 
results are positive.  
4. Clinical assessment of the treatment area for any epidermal, 
dermal and subcutaneous findings (e.g., erythema, bruising, 
swelling, pigment changes) as well as alterations in sensation 
(e.g., numbness, tingling).  
5. Assessment of any adverse events.  
6. Subject feedback via a questionnaire.  
7. Photography of torso region using the same standardized setup 
and settings as the pre-treatment photographs (optional).  
8. Obtain 3-Dimensional images (optional). 

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9. Obtain ultrasound images of the treated area. Ultrasound will 
be performed by Sponsor staff. (Optional) 
10. Perform treatment as described in Section 6.6.1.  A minimum 
of eight treatment cycles will be performed in the study.  
 
 Follow-up Procedures 
6.7.1. 
One-Week Phone Follow-Up (post-each treatment); Required: 
7 Days (± 3 days)  
Subjects will be contacted (via phone call or email) one week 
after Treatment Visit #1 and Treatment Visit #2 to: 
1. Obtain information regarding the condition of the treatment 
area 
2. Obtain subject pain score 
3. Assess for adverse events 
 
If there is evidence that an adverse event may have occurred, the 
subject may be asked to come in for a visit so an appropriate 
evaluation can be performed.   

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6.7.3. 
Twelve-Week Final Follow-up; Required (Day 90 +/- 14 days 
post-treatment)  
The following evaluations will be performed at the 12-week final 
post-treatment follow-up visit:  
 
1. Obtain weight.  
2. Clinical assessment of the treatment regions for any epidermal, 
dermal and subcutaneous findings (e.g., erythema, bruising, 
swelling, pigment changes) as well as alterations in sensation 
(e.g., numbness, tingling).  
3. Assessment of any adverse events.  
4. Subject feedback via questionnaire.  
5. Standardized and 3D photography of the torso using the same 
standardized setup and settings as the pre-treatment 
photographs. 
6. Obtain ultrasound images of the treated area. Ultrasound will 
be performed by Sponsor staff. (Optional) 
 
6.7.4. 
Optional Follow-Up Evaluations (up to 2 within study period)  
The full evaluation is not required at optional follow-up visits; the 
extent of the assessment will be at the discretion of the investigator.  
Study activities and events are summarized in Table 1, Study 
Schedule. 

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Table 2.  Study Schedule 
 
Study Task 
Screening 
visit 
(< 1 hr)
Photo Visit 
(< 1 hr) 
Treatment  
#1 
(</=  4 hrs)
Treatment  
#2 
(</=  4 hrs)
1-Week 
Phone 
F/U† 
4-Week 
F/U Visit† 
12-Week  
F/U Visit 
 
Optional 
F/U 
Visit** 
Day -60 to 0 
Day-30 to 1 
Week 1 
Week 6 
Weeks  
2 and 7
30 days 
(± 7 d) 
90 days  
(+/- 14 d) 
Open 
Informed Consent 
X 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
 
X 
X 
 
 
 
 
Pregnancy Test 
X 
 
X 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
Weight 
X 
X 
X 
X 
 
X 
X 
 
Photography-2D & 3D 
Baseline & 3 month 
required
 
X* 
 
X* 
 
X* 
X* 
 
Ultrasound (optional) 
 
X* 
 
X* 
 
X* 
X* 
 
Satisfaction Questionnaire 
 
 
 
X 
 
X 
X 
 
CoolSculpting Treatment 
 
 
X 
X 
 
 
 
 
Pain Assessment 
 
 
X 
X 
X 
X 
X 
 
AE Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X* indicates procedures which may be performed by staff of the Sponsor 
** Investigator discretion as to timing and extent of follow-up assessment for optional visits.  
† Follow-up after each treatment 

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7. Statistical Methodology and Analyses 
 Primary Endpoints 
The primary endpoints of the study are defined as follows:  
 Safety Endpoint: The frequency of device-related adverse events (AEs) 
including device-related serious adverse events (SAEs) will be summarized. 
 
 Efficacy Endpoint: The primary effectiveness endpoint is the correct 
identification of pre-treatment vs. 12-Week post-treatment images by at least 
two out of three blinded, independent reviewers. Success is defined as at least 
70% correct identification of the pre-treatment images.  
 Statistical Methods: Overall Plan 
Data will be summarized based on the nature of the data. Dichotomous (e.g., gender, 
independent photographic review) and ordinal (e.g., Fitzpatrick Skin type) data will be 
tabulated by category. The mean, standard deviation, maximum, and minimum will be 
tabulated for continuous data (e.g., age, fat thickness). The significance level will be 
two-sided 0.05 for all statistical tests. 
 Analysis Cohorts 
7.3.1. 
Safety Cohort  
This cohort will consist of all the treated participants with safety evaluation 
after the treatment.  This cohort should be identical to the As Treated (AT) 
cohort.  The safety data analyses will be performed based on the Safety 
Cohort. 
7.3.2. 
Effectiveness Cohorts 
Two groups of subjects will be identified for the analysis of effectiveness 
endpoints:  Per Protocol Cohort and the As Treated Cohort.  All analyses of 

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effectiveness will be performed on each cohort of subjects.  However, study 
success will be based on the Per Protocol Cohort of subjects. 
 
Per-protocol Cohort (PP): 
The Per-protocol Population will consist of all the treated subjects 
(completing 2 treatment sessions with at least 8 total cycles) followed 
through to the final post-treatment visit and with weight change of no more 
than ±5% at the time the final post-treatment visit images are taken. Since a 
weight change of more than 5 percent will affect the images, the primary 
efficacy analysis will be performed based on this study population.  
 
As-Treated Cohort (AT): 
This cohort consists of all treated participants regardless of whether they 
become pregnant or undergo weight change during the study.   
7.3.3. 
Endpoint Analysis 
Primary Safety Endpoint  
The primary safety endpoint will be the frequency of device-related adverse 
events (AEs) including device-related serious adverse events (SAEs).  The 
number and percentage of subjects experiencing each AE will be 
descriptively summarized. Adverse events and SAEs will be presented as 
summary tables showing the frequency and type of events.  
 
Primary Efficacy Endpoint:  
The primary efficacy endpoint is the correct identification of pre- treatment 
vs 12-week post-treatment images. Since weight change will affect the 
image, the analysis will be based on the evaluation of the PP population, i.e. 
treated subjects followed for 12 weeks who did not became pregnant, and 
with weight change of no more than ±5% at the 12-week visit. Success will 
be defined as at least 70% correct identification of the pre-treatment images.  
7.3.4. 
Missing Data Handling:  
In general, no imputation for missing data will be made. Data will be 
analyzed “as-is” where subjects with missing data not being included in the 
analysis. 

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7.3.5. 
Data Pooling:  
Data are assumed to be poolable across sites due to: 1) use of the same study 
protocol, 2) equivalent training of all sites in the study protocol and use of 
the investigational device, 3) use of the same CRF at each site, and 4) use of 
Independent Evaluator(s).  
8. Adverse Events 
Adverse events (AE) will be assessed continuously throughout the study. An 
AE is defined in accordance with ISO 14155 as any untoward medical 
occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in study participants, users, or other persons 
temporally associated with the use of study treatment, whether or not 
considered related to the study treatment. 2 
Disease signs and symptoms that existed prior to the study treatment are not 
considered AEs unless the condition recurs after the patient has recovered 
from the pre-existing condition or the condition worsens in intensity or 
frequency during the study. 
AEs will be monitored throughout the study beginning with signing of 
informed consent. At each post-baseline visit, the investigator will begin 
querying for AEs by asking each patient a general, non-directed question such 
as “Have you had any changes to your condition since your last visit?” 
Previous AEs and changes in therapy/concomitant medications are to be 
updated. Directed questioning and examination will then be done as 
 
 
 
2 Clinical Investigation of medical devices for human subjects – Good Clinical Practice (ISO 14155:2011) 

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appropriate. All reportable AEs and clinically significant abnormal laboratory 
findings will be documented on the appropriate CRF. 
Adverse events will be reported by the participant (or, when appropriate, by a 
caregiver, surrogate, or the participant's legally authorized representative). The 
investigator and any designees are responsible for detecting, collecting and 
recording events that meet the definition of an AE or SAE and remain 
responsible for following up AEs that are serious, considered related to the 
study treatment or study procedures, or that caused the participant to 
discontinue the study until the event has resolved or until 30 days after the 
completion of the study. 
 Adverse Device Effect (ADE) 
Any sign, symptom, or disease in a study subject that occurs during the 
course of a clinical trial that is determined by the Investigator to have a 
causal relationship or possible causal relationship with the device under 
investigation. This definition includes any AE s resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device as well as 
any event resulting from use error (per ISO 62366) or from intentional 
misuse of the investigational medical device. 
8.1.1. 
Serious Adverse Device Effect (SADE) 
A serious adverse device effect (SADE) is defined in 
accordance with ISO 14155 as “an adverse device effect that 
has resulted in any of the consequences characteristic of a 
serious adverse event.” 
8.1.2. 
Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated serious adverse device effect (USADE) is 
defined in accordance with ISO 14155 as “any serious adverse 
device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the 
risk analysis report.” The investigator is to consult the IFU for 
anticipated risks or anticipated AEs. 

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8.1.3. 
Serious Adverse Event (SAE) 
An SAE is defined in accordance with ISO 14155 as an AE that: 
1. Led to death 
2. Led to serious deterioration in the health of the 
patient, that either resulted in: 
a. a life-threatening illness or injury, or 
b. a permanent impairment of a body structure or a body function, or 
c. inpatient or prolonged hospitalization, or 
d. medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment 
to a body structure or a body function, or 
e. led to fetal distress, fetal death or a congenital 
abnormality or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, 
or a procedure required by the protocol, without serious 
deterioration in health, is not considered an SAE. 
8.1.4. 
Time Period and Frequency for Collecting AE and SAE Information 
All AEs and SAEs from the signing of the Informed Consent Form (ICF) 
until the last follow-up visit will be collected at the time points specified in 
the schedule of activities, and as observed or reported spontaneously by study 
participants. 
Medical occurrences that begin after signing of informed consent and before 
administration of study treatment will be recorded as an AE on the 
appropriate CRF. 
All SAEs will be recorded and reported to the Sponsor or designee within 24 
hours of learning about the report. All non-serious AEs related to the devices 
used in the study, as well as Device Complaints, will be reported to the 
Sponsor within 7 working days. The investigator will submit any updates on 
these events to the Sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE in former study 
participants. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed the final visit of the 

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study, and he/she considers the event to be reasonably related to the study 
treatment or study participation, the investigator must promptly report the 
event to the Sponsor. 
8.1.5. 
Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. 
Open-ended and non-leading verbal questioning of the participant is the 
preferred method to inquire about possible AEs. 
8.1.6. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively 
follow each participant at subsequent visits/contacts. All SAEs will be 
followed until resolution, stabilization, the event is otherwise explained, or 
the participant is lost to follow-up or until 30 days after completion of the 
study. 
The investigator is obligated to perform or arrange for the conduct of 
supplemental measurements and/or evaluations as medically indicated or as 
requested by the Sponsor to elucidate the nature and/or causality of the AE or 
SAE as fully as possible. This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other 
health care professionals. 
New or updated information will be recorded in the originally 
completed CRF. 
The investigator will submit any updated SAE data to the 
Sponsor within 24 hours of receipt of the information. 
8.1.7. 
Reportable Incidents 
Serious adverse events (SAEs and SADEs) as well as unanticipated adverse 
device effects (UADEs) must be reported within 24 hours of knowledge of 
the event to the Sponsor. 
All adverse events observed by the investigator or reported by the subject 
will be recorded on the appropriate CRF, irrespective of the relationship to 
the investigational device used in the study. Medically significant adverse 
events will be followed until resolved or considered stable. For each event, 
the investigator will record a description, dates of onset and resolution, 
severity, and relationship to the investigational device. The investigator may 

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be required to provide follow-up information as-needed to fulfill 
requirements for regulatory reporting. 
Any adverse event that results in withdrawal from the study must be reported 
to the Sponsor after the decision to withdraw the subject is made. 
Any death occurring during the study must be reported to the Sponsor within 
24 hours.  
If an event is classified as an SADE or a UADE, the Sponsor will determine 
if there is an unreasonable risk to the patients within the study.  In the event a 
UADE is reported during this study, it will be reported to the IRB and to the 
regulatory agencies as appropriate according to the relevant standard 
operating procedures and law of the country where the trial is performed.  
8.1.8. 
Assessment of Severity 
Severity of adverse events will be determined using the following 
scale: 
• 
Mild: Event that is easily tolerated and may require only 
minimal treatment or therapeutic intervention. The event does 
not generally interfere with usual activities of daily living. 
• 
Moderate: Events that interfere with usual activities of daily 
living, causing discomfort but poses no significant or 
permanent risk of harm to the research participant. It is 
usually alleviated with additional specific therapeutic 
intervention. 
• 
Severe: Event that is incapacitating, with inability to work 
and do the usual activities of daily living, or significantly 
affects clinical status. This may require intensive therapeutic 
intervention. 
8.1.9. 
Assessment of Relatedness 
 
The investigator is obligated to assess the relationship between 
study treatment and each occurrence of each AE/SAE. 
 
A reasonable possibility of a relationship conveys that there 
are facts, evidence, and/or arguments to suggest a causal 
relationship, rather than a relationship cannot be ruled out. 

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 
The investigator will use clinical judgment to determine the relatedness. 
 
Alternative causes, such as underlying disease(s), concomitant 
therapy, and other risk factors, as well as the temporal 
relationship of the event to study treatment administration will 
be considered and investigated. 
 
The investigator will also consult the investigator’s brochure 
and/or product information, for marketed products, in his/her 
assessment. 
 
For each AE/SAE, the investigator must document in the 
medical notes that he/she has reviewed the AE/SAE and has 
provided an assessment of relatedness. 
 
For each AE/SAE, there are 4 levels of relatedness, as follows: 
• 
Not related 
• 
Possible 
• 
Probable 
• 
Definite relationship 
There may be situations in which an SAE has occurred and the investigator 
has minimal information to include in the initial report to the Sponsor. 
However, it is very important that the investigator always make an 
assessment of relatedness for every event before the initial transmission of 
the SAE data to the Sponsor. 
 
The investigator may change his/her opinion of relatedness in 
light of follow-up information and send an SAE follow-up 
report with the updated relatedness assessment. 
 
The relatedness assessment is one of the criteria used when 
determining regulatory reporting requirements. 
 
The investigator will determine the relationship of each adverse event to the 
study device using the question: "Is there a reasonable possibility that the 

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event may be related to treatment with the device? Answer 'yes' or 'no' for 
each adverse event." 
The guideline below should be used to consider relatedness: 
For a “not related” assessment, the adverse event: 
• 
May be judged to be due to extraneous causes such 
as disease or environment or toxic factors 
• 
May be judged to be due to the subject's clinical state or 
other therapy being administered 
• 
Is not biologically plausible 
• 
Does not reappear or worsen when the investigational 
device is re-administered 
• 
Does not follow a temporal sequence from treatment with 
the investigational device,  
For an assessment of relatedness (including, probable and 
possible assessments) there is a reasonable possibility that the 
event may have been caused by the investigational device, the 
adverse event: 
• 
Follows a temporal sequence from treatment with the 
device.   
• 
Is a known response to the device based on clinical or 
nonclinical data 
• 
Could not be explained by the known characteristics of the 
subject's clinical state, environmental or toxic factors, or other 
therapy administered 
• 
Disappears or decreases upon cessation of the use 
of the device.   
 
Reappears or worsens when the device is re-
administered.  

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8.1.10. 
Serious Adverse Event Reporting Procedures 
All serious adverse events must be reported to the Sponsor within one (1) 
working day of discovery or notification of the event and according to 
IEC/IRB requirements and the institution at which the study is conducted, if 
applicable. Serious adverse event information and any follow-up information 
will be recorded on a Serious Adverse Event Form and transmitted to the 
Sponsor using the contact information provided by the Sponsor. Note that for 
each device used in this study, a separate SAE form and contact information 
will be used.  The Sponsor is responsible for evaluating and reporting any 
serious adverse event and unexpected serious adverse reactions in accordance 
with all applicable laws and standards.  
Reportable Incidents 
Serious adverse events (SAEs) and unanticipated adverse device effects 
(UADEs) must be recorded and reported to the Sponsor or designee within 
24 hours of knowledge of the event to the Sponsor: 
 
 
ZELTIQ Aesthetics, an Allergan affiliate  
4410 Rosewood Dr. 
Pleasanton, CA 94588 
PH: 
  
Email:  
 
 
A full reporting of the event shall be provided within 10 working days of the 
event.  The Sponsor is then responsible for notifying the IRB, as required. 
Other adverse events, deemed by the Investigator to be non-serious, should be 
provided to the Sponsor as soon as possible and not later than 1 week after 
knowledge of the event. This will be forwarded to the Product Surveillance 
team within 24 hours of receipt by the Sponsor Contact.  
Additional information obtained by the Clinical Site regarding any adverse 
event, both serious and non-serious, will be reported to the Sponsor within 24 
hours of awareness.  
Safety Monitoring Considerations 

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If an adverse event occurs that in the judgment of the investigator represents a 
potential risk for new subjects, the investigator will contact the Sponsor within 
1 working day after becoming aware of the event. 
A full reporting of the event shall be provided within 10 working days of the 
event. The Sponsor is then responsible for notifying the IRB/EC, as required. 
8.1.11. 
Pregnancy 
 
Details of all pregnancies in female participants will be 
collected after the start of study treatment through the 
duration of the pregnancy. 
 
If a pregnancy is reported, the investigator should inform 
the Sponsor within 24 hours of learning of the pregnancy. 
 
If a female of childbearing potential becomes pregnant 
during the study, the investigator should notify the 
participant’s physician that the participant may have been 
treated with the investigational device and exit the participant 
from the study. 
 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, 
fetal death, stillbirth, congenital anomalies, ectopic 
pregnancy) are considered SAEs.  
9. Device Tracking 
The Sponsor will send the Investigator investigational devices. The Investigator must house 
study devices in an appropriate, secure location.   
The Sponsor will track sending and receiving of devices to/from the Investigator. The 
Investigator must track receipt and final disposition of the devices, and maintain accurate 
records of the use of the device on each study subject.   
In addition, for IDE studies, the Investigator must maintain records of receipt, use and 
disposition of all devices on a device accountability log which will be monitored by the 
Sponsor and a copy collected at the end of the study. An accurate record of the date the 
device was used on each subject must be available for inspection at any time. 
 
Device Packaging and Labeling 
Clinical study devices will be packaged and labeled according to the country’s regulatory 
requirements.  

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The study device or its immediate package, will be labeled per the requirements of 
21CFR 812.5(a).  
10. Device Deficiencies and Malfunctions 
A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical 
device with respect to its identity, quality, durability, reliability, safety, or performance.” 
Device deficiencies include malfunctions, use errors, and inadequate labeling. 
If a device deficiency occurs, the investigator will notify the Sponsor. Device deficiencies 
shall be documented throughout the study and appropriately managed and reported to 
regulatory authorities and IRBs as required by national regulations.  
11. Ethical and Regulatory Considerations 
 
Compliance with Good Clinical Practice 
This study will be conducted in compliance with the principles of the Declaration of 
Helsinki, with the current Good Clinical Practice (GCP) guidelines and with other 
applicable regulations. The Investigator and all study staff will conduct the study in 
compliance with this protocol. Voluntary informed consent will be given by every subject 
prior to the initiation of any study-related procedures. The rights, safety and well-being of 
the study subjects are the most important considerations and prevail over the interests of 
science and society. All personnel involved in the conduct of this study must be qualified 
by education, training and experience to perform their assigned responsibilities. 
 
Institutional Review Board (IRB) and Informed Consent 
Before study initiation, the Investigator must have written and dated approval from the 
IRB/EC for the protocol, consent form, subject recruitment materials/process (e.g., 
advertisements), and any other written information to be provided to subjects. The 
Investigator should also provide the IRB/EC with a copy of the product labeling, 
information to be provided to subjects and any updates. The Investigator will submit 
documentation of the IRB/EC approval to the Sponsor. Copies of all correspondence with 
the IRB/EC regarding this study must be sent to the Sponsor. 
The IRB/EC-approved consent form must include all elements required by FDA, state, 
and local regulations, and may include appropriate additional elements. 
The Investigator/designee will explain the study to each potential subject and the subject 
must indicate voluntary consent by signing and dating the approved informed consent 
form. The Investigator must provide the subject with a copy of the consent form in a 

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language the subject understands. The Investigator will maintain documentation that 
informed consent was obtained prior to the initiation of any study-specific procedures. 
Withdrawal of IRB/EC approval of the Investigator’s part in the investigation must be 
reported to the Sponsor within 5 working days. 
 Protocol Adherence 
The study investigators are responsible for performing the study in compliance with the 
protocol.   Non-adherence to the protocol is to be classified as a protocol violation, 
protocol deviation, as defined below. 
Protocol Violation 
Non-adherence to the protocol that may result in significant additional risk to the 
participant (e.g., enrollment of a participant who does not meet the study criteria).  Or, 
non-adherence to Good Clinical Practices (GCP) that may impact patient safety (e.g., 
failure to obtain proper consent prior to performing study procedures).  Violations should 
be reported to the study Sponsor and the IRB within 5 working days if they occur. 
Protocol Deviation 
Non-adherence to study procedures which does not result in additional risk to the 
participant (e.g., participant missed visit).  Protocol deviations are not required to be 
reported to the IRB; however, they must be recorded and addressed on the study case 
report forms and may be reported and reviewed in conjunction with the progress report as 
part of the annual review process. 
Protocol Waivers 
Waivers, exceptions or any intentional deviation from the approved protocol are not 
permitted in the study. 
 Protocol Amendments 
Amendments to the study protocol can be made only by the study Sponsor. A revised 
protocol can be put into place only after governing IRB/EC approval.  All administrative 
letters must be submitted to the IRB/EC for their information.  
New or altered consent forms required by the IRB due to a protocol change must be used 
for any subsequent subject enrollment and when the IRB requires, signed by subjects 
currently enrolled in the study. 

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12. Study Management and Quality Control  
 Study Data Collection   
Zeltiq will supply Case Report Forms (CRFs) to all participating sites for this study.  
A CRF is required and will be completed for each included subject. The Investigator has 
ultimate responsibility for the collection and reporting of all data entered on the CRFs 
and any other data collection forms (source documents) and ensuring that they are 
accurate, authentic/original, attributable, complete, consistent, legible, timely 
(contemporaneous), enduring and available when required. The CRFs must be signed by 
the Investigator to attest that the data contained therein are true.  
Paper Based CRFs 
Demographic, Screening (Inclusion/Exclusion), Treatment, Follow Up, Adverse Event, 
Protocol Deviation, and Study Termination Data will be recorded on paper Case Report 
Forms (CRFs) developed by the Sponsor.  Completed CRFs will be monitored by the 
Sponsor or a designee at defined intervals and the original CRFs will be collected.  
Copies will remain filed at the investigational sites.  The data will then be reviewed by 
the Sponsor and entered into a study database.  Data queries will be issued as necessary 
to clarify discrepancies.  
  Data Management 
Data management activities will be performed in accordance with internal Zeltiq SOPs 
for handling data in non-significant risk studies conducted under abbreviated IDE 
requirements. 
12.2.1. 
Data Receipt and Data Entry 
The monitor will collect clinical study related documents including Case Report 
Forms (CRFs), Data Clarification Forms (DCFs), and any other clinical 
documents from clinical sites and transmit the documents to the Sponsor as 
appropriate.   
 Confidentiality 
All information and data concerning study participants will be considered confidential, 
and handled in compliance with all applicable regulations including the requirements of 
the Health Insurance Portability and Accountability Act (HIPAA) of 1996. 

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The investigator is responsible for ensuring the confidentiality of subjects throughout the 
trial.  A unique identification code will be assigned to each subject participating in this 
trial.  Any data that may be published in abstracts, scientific journals, or presented at 
medical meetings will reference a unique subject code and will not reveal the subject’s 
identity.  
Only authorized site staff, the study Sponsor or the Sponsor’s designee, IRB/EC or 
regulatory authorities will have access to these confidential files. All data used in the 
analysis, reporting and publication of this clinical trial will be maintained without 
identifiable reference to the participant. Any data that may be published in abstracts, 
scientific journals, or presented at medical meetings will reference a unique participant 
code and will not reveal the participant’s identity. 
 Quality Assurance Audits 
Sponsor representatives or designees may conduct site quality assurance (QA) audits 
during the study.  The Investigator must agree to provide the auditor with direct access 
to all relevant documents and discuss any findings with the auditor. 
In the event of an inspection by the FDA or other regulatory authorities, the Investigator 
must give the inspector direct access to relevant documents and to discuss any findings 
with the inspector. The Investigator must notify Zeltiq in the event of a FDA site audit. 
 Investigator Responsibilities 
12.5.1. General Responsibilities  
Investigators are responsible for ensuring the investigation is conducted 
according to all signed agreements, the Protocol, and applicable FDA 
regulations.  The investigator must protect the rights, safety, privacy and 
welfare of the participants under the Investigator’s care. Investigators will 
assume overall responsibility and accountability for study site staff and for 
the clinical data obtained during the study.  The investigator assumes all 
responsibilities per applicable regulations, including but not limited to: 
IRB approval: The investigator may not begin the study until the FDA and 
the governing institutional review board (IRB) provide written approval of 
the study protocol and consent form.  The investigator is also responsible for 
fulfilling any conditions of approval imposed by the IRB. 
Informed Consent: The investigator must ensure that informed consent is 
obtained from each prospective study participant in accordance with 21 CFR 

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Part 50 and that the study is not commenced until FDA and IRB approvals 
have been obtained.   
Financial Disclosure:  Investigators shall provide financial disclosure 
according to federal regulations.  
Study Coordinator:  To assure proper execution of the study protocol, each 
investigator must identify a study coordinator for the site who will work with 
and under the authority of the investigator to assure that study requirements 
are fulfilled as appropriate.  
12.5.2. 
Investigator Records   
The investigator and study staff must maintain accurate, complete, and 
current records relating to the conduct of the investigation.  Records must be 
retained for a period of two years following (1) the date the investigation was 
completed or terminated, or (2) the records are no longer required to support 
a regulatory submission or completion of a product development protocol, 
whichever is longer.  Participating investigators shall maintain the following:  
 All correspondence with the Sponsor, another investigator, the IRB, a 
monitor, or the FDA 
 Records of all persons authorized to conduct the study (e.g. 
Delegation of Duties/Signature Authorization, CV) 
 Records of receipt, use or disposition of the device 
 Informed Consent documentation for all enrolled participants 
 Records of each participant's case history, including study-required 
Case Report Forms and source documentation (e.g. physician notes, 
lab reports, study worksheets, clinic charts) 
 All relevant observations of adverse device effects 
 Records of any protocol deviations 
 The condition of each participant upon entering and during the course 
of the investigation and any relevant medical history and results of 
any diagnostic tests 
 Record of each participant’s exposure to the device, including the 
date and time of use 

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 Protocol with all amendments 
 Current IRB approved informed consent and all previously approved 
versions 
 Signed Investigator Agreement 
 Investigators will be responsible for the accurate and timely 
completion of CRFs during the trial.   
These records must be available and suitable for inspection at any time by 
Sponsor representatives (monitor), the reviewing IRB, or FDA. The 
Investigator will supply access to study-related medical records, original 
laboratory data, and other records and data as they relate to the trial.  The 
investigator will ensure that both he/she and his/her study staff have adequate 
time and resources to devote to the study, including study enrollment, 
participant evaluations, study documentation and site monitoring. 
12.5.3. 
Investigator Reports   
The investigator is responsible for preparation and submission of the 
following reports: 
 Report of any unanticipated adverse device effects shall be submitted 
to the Sponsor within 24 hours and no later than 10 working days 
after the Investigator first learns of the effect 
 Withdrawal of IRB approval of the investigator’s part in the 
investigation shall be reported to the Sponsor within 5 working days 
 Progress reports on the investigation to the sponsor, the monitor, and 
the reviewing IRB annually. Alternatively, the Sponsor may prepare 
the report.  
 Deviations from the protocol shall be reported to the Sponsor and the 
IRB 
 Failure to obtain informed consent prior to use of a device in a 
participant shall be reported to the Sponsor and IRB within 5 working 
days after the use occurs 
 A final report shall be submitted to the Sponsor and IRB within 3 
months after termination or completion of the investigation, or the 
investigator’s part of the investigation.  

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 Sponsor Responsibilities  
12.6.1. 
General Responsibilities: 
As the Sponsor, ZELTIQ Aesthetics assumes overall responsibility for the 
conduct of the study including assurance that the study satisfies applicable 
regulatory requirements. ZELTIQ Aesthetics assumes all responsibilities per 
applicable regulations, and shall: 
IRB approval:  Ensure IRB approval for the investigation. No IDE 
application is necessary for this study. 
Investigators:  Select investigators qualified by training and experience, and 
providing them with the information they need to conduct the study properly.  
Obtain a signed Investigator Agreement from each participating investigator. 
Study sites will be evaluated to ensure that they have an adequate participant 
base and can provide sufficient staff and documentation support to conduct 
the study properly. 
Monitoring:  Select monitors qualified by training and experience and 
ensure proper monitoring of the study. 
Data Management and analysis:  Ensure data collection, verification, 
analysis, records storage, etc. Sponsor will assist with presentation(s) and/or 
publication(s). 
Essential Document Records:  Maintain all Essential Documents pertaining 
to the study per ISO 14155:2011. Records must be retained for a period of 
two years following (1) the date the investigation was completed or 
terminated, or (2) the records are no longer required to support a regulatory 
submission or completion of a product development protocol, whichever is 
longer. 
Study Training: To ensure uniform data collection and protocol compliance, 
Sponsor personnel will provide an educational session to study site personnel 
which will cover the Protocol, techniques for the identification of eligible 
participants, data collection and form completion, and the device directions 
for use.  The investigator and study staff will be trained on the study device 
and protocol, applicable regulations and requirements, and expectations of 

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the study, enrollment expectations, participant selection, informed consent, 
required clinical data and record keeping, etc.   
Device Use: Representatives of the Sponsor will train investigators in use of 
the study device. 
12.6.2. 
Site Monitoring  
The Sponsor will ensure that qualified clinical monitors are available to 
monitor and oversee the conduct of the trial and that monitoring is performed 
in accordance with the Sponsor’s approved procedures or third-party 
procedures approved by the Sponsor.  
The clinical monitors will evaluate compliance with the protocol and 
applicable regulations, any specific recommendations made by the site’s IRB 
and the signed Investigator Agreement.   
Monitoring Visits 
On-site monitoring visits will assess the progress of the clinical study and 
identify any concerns that result from device performance or review of the 
investigator’s study records, study management documents, and informed 
consent documents.   
Monitoring will ensure continued protocol compliance, accurate data 
reporting, and adequate accounting of shipments of study devices.  
The study design includes two treatment visits with the final visit occurring 3 
months post-final treatment. A monitoring visit will occur after the treatment 
visits are completed, and at least one additional monitoring visit will occur at 
each site prior to, or in conjunction with, study closeout.  
In the event that monitoring identifies serious and/or persistent 
noncompliance of an investigator, the issue will be escalated to Zeltiq 
Clinical management.   
During monitoring visits, the monitor will compare participant records and 
other supporting documents with reports at the site to determine that: 
 The facilities used by the investigation continue to be acceptable 
for the purposes of the clinical study 

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 Informed consent was properly obtained and documented for all 
enrolled study participants 
 The protocol is being followed, and only eligible participants are 
being enrolled into the study 
 Deviations to the Protocol have been reported to ZELTIQ and the 
IRB, as appropriate 
 Adverse events are promptly being reported 
 Device accountability is being maintained 
 Information recorded in the case report forms and study reports are 
accurate, complete, legible and consistent with source 
documentation 
 Participants failing to complete the clinical study and the reason 
for failure are recorded 
 Missed follow-up visits are noted in the study documentation 
Clinical monitors will provide feedback to the site regarding protocol or 
study compliance.  If monitoring reveals significant Investigator 
noncompliance with the study agreements, protocol, applicable regulations, 
IRB approval conditions, the monitor will notify Sponsor Clinical 
Management. Action will be taken to secure compliance, and if further 
compliance problems persist, or the issue is deemed serious (i.e. endangering 
patient welfare or safety), the site may be removed from the study and/or the 
investigator disqualified from future studies. 
Study Site Closeout   
At the close of the study at an investigational site, the monitor will make a 
final on-site visit to ensure that all case report forms have been monitored 
and retrieved and that the investigator’s files are accurate and complete. The 
monitor will ensure that all investigational devices and study supplies are 
accounted for, and provide for appropriate disposition of any remaining 
supplies. The monitor will review record retention requirements with the 
investigator and any remaining investigator obligations are reviewed and 
ensure that all applicable requirements are met for the study.  The monitor 
will prepare a report of the site closeout visit. The closeout visit may be 
combined with a final monitoring visit. 

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12.6.3. 
Final Report  
A final report will be prepared at the conclusion of the trial. Copies of the 
final report will be provided to each investigator and to the respective IRBs. 
12.6.4. 
Trial Registration  
When appropriate, prior to study initiation, the trial will be registered on a 
publicly accessible study database such as clinicaltrials.gov.  
13. Data Ownership 
ZELTIQ Aesthetics, the study Sponsor, retains ownership of all data generated in 
this study, and controls the use of the data for purposes of regulatory submissions 
to the US and/or other governments. Investigator(s) and institution(s) (which shall 
include their employees, agents, and representatives) may not issue or disseminate 
any press release or statement, nor initiate any communication of information 
regarding this study (written or oral) to the communications media or third parties 
without the prior written consent of the Sponsor.  

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