Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring
Phase: NA
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics



ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 3 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
 
 
 
 
INVESTIGATOR SIGNATURE PAGE 
 
For protocol number ZA17-004 
 
 
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 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 
 
 
 
 
________________________          _______________ 
_______ 
Co- Investigator printed name          Signature 
 
Date  
 
 
 
 
 
RETURN PAGE TO SPONSOR 
 
 
 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 4 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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 ................................................................................................. 6 
2. 
Introduction ............................................................................................................ 7 
2.1. 
Background .............................................................................................................. 7 
2.2. 
Device Description ..................................................................................................10 
2.3. 
Regulatory Status ....................................................................................................11 
3. 
Study Protocol ...................................................................................................... 11 
3.1. 
Design ......................................................................................................................11 
3.2. 
Study Duration .........................................................................................................11 
3.3. 
Physician Participants ............................................................................................11 
3.4. 
Site Requirements ...................................................................................................11 
3.5. 
Subject Recruitment ................................................................................................11 
3.6. 
Sample Size .............................................................................................................12 
3.7. 
Subject Eligibility .....................................................................................................12 
3.8. 
Informed Consent ....................................................................................................13 
3.9. 
Screening Procedures .............................................................................................13 
Screening Visit; Required; Day -45 to Day 0 ...................................................................................... 13 
3.10. 
Study Enrollment .....................................................................................................14 
3.11. 
Study Photography ..................................................................................................14 
3.12. 
Study Treatment Procedures ..................................................................................15 
3.12.1. 
Treatment Visit #1; Required: Day 0 ................................................................................. 15 
3.12.2. 
Treatment Visit #2; Optional: Week 6 post-Treatment #1 (± 1 week) ............................... 16 
3.13. 
Follow-up Procedures .............................................................................................16 
3.13.1. 
1-Week Follow-Up Visit; Required: Day 7 (± 3 days) ....................................................... 16 
3.13.2. 
3-Week Follow-Up Visit; Required: Week3 (± 7 days) ...................................................... 17 
3.13.3. 
6-Week Follow-Up Visit; Required: Week 6 (± 7 days) ..................................................... 17 
3.13.4. 
12-Week Final Follow-Up Evaluation; Required (12 weeks ± 14 days post 2nd treatment)
 
17 
3.13.5. 
Optional Follow-Up Evaluations (up to 4 within study period) .......................................... 18 
3.14. 
Assessments ...........................................................................................................20 
3.14.1. 
Safety Assessments.......................................................................................................... 20 
3.14.2. 
Photography ...................................................................................................................... 20 
3.14.3. 
Caliper Measurement ........................................................................................................ 21 
3.14.4. 
Ultrasound Measurement .................................................................................................. 21 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
3.14.5. 
Subject Satisfaction........................................................................................................... 21 
3.15. 
Endpoints .................................................................................................................21 
3.15.1. 
Primary Endpoints ............................................................................................................. 21 
3.15.2. 
Secondary Endpoints ........................................................................................................ 22 
3.16. 
Statistical Analysis Plan .........................................................................................22 
3.16.1. 
Statistical Methods: Overall Plan ...................................................................................... 22 
3.16.2. 
Analysis Population ........................................................................................................... 22 
3.16.3. 
Endpoint Analysis .............................................................................................................. 23 
Primary Safety Endpoint: ............................................................................................................................... 23 
Primary Efficacy Endpoint: Photographic Review ......................................................................................... 23 
Secondary Endpoint: Reduction in Fat Layer Thickness as Measured by Ultrasound ................................... 23 
Secondary Endpoint: Subject Satisfaction ..................................................................................................... 24 
3.17. 
Protocol Adherence .................................................................................................24 
3.18. 
Adverse Events ........................................................................................................24 
3.19. 
Reportable Incidents ...............................................................................................25 
4. 
Study Management and Quality Control ............................................................ 26 
4.1. 
Study Data Collection ..............................................................................................26 
4.2. 
Confidentiality ..........................................................................................................26 
4.3. 
Investigator Responsibilities ..................................................................................26 
4.3.1. 
General Responsibilities ................................................................................................... 26 
4.3.2. 
Investigator Records ......................................................................................................... 27 
4.3.3. 
Investigator Reports .......................................................................................................... 28 
4.4. 
Sponsor Responsibilities ........................................................................................29 
4.4.1. 
General Responsibilities ................................................................................................... 29 
4.4.2. 
Training ............................................................................................................................. 29 
4.4.3. 
Monitoring ......................................................................................................................... 30 
4.4.4. 
Final Report ....................................................................................................................... 31 
4.4.5. 
Trial Registration ............................................................................................................... 31 
5. 
Data Ownership .................................................................................................... 31 
6. 
Publication Policy ................................................................................................ 31 
7. 
Risk/Benefit Analysis ........................................................................................... 31 
7.1. 
Benefits ....................................................................................................................31 
7.2. 
Risks .........................................................................................................................31 
 
 

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Part Number: 
Revision: 02
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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
Note: Check with Document Control for current revisions of all referenced documents.
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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.
Figure 1: Study Visit Flowchart.  All visits require subjects to return to the study site except for the 1-week and 3-week 
Follow-up phone/email.   
*Follow-up conducted remotely via phone call or email

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 11 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
2.3. 
Regulatory Status 
In Canada, the ZELTIQ CoolSculpting System is licensed (
) and approved 
for:  
 
 Fat layer reduction through cold-assisted lipolysis 
 Minimizing pain and thermal injury during laser and dermatological treatments 
 Acting as a local anesthetic for procedures that induce minor local discomfort 
 
The ZELTIQ system can also provide localized thermal therapy (hot or cold) to minimize 
pain for post-traumatic and/or post-surgical pain and to temporarily relieve minor aches 
and pains and muscle spasms. The optional massage function can also be used for 
temporary: 
 
 Relief of minor muscle aches, pain and spasm 
 Improvement in local circulation 
 The CoolSculpting System also received Health Canada approval in September 2015 
for colder temperatures and shorter treatment times. 
3. Study Protocol 
3.1. 
Design 
Prospective, non-randomized interventional cohort. 
3.2. 
Study Duration  
Enrollment and follow-up is expected to take up to six (6) months for each subject. 
3.3. 
Physician Participants 
Study investigators must be practicing medical physicians with experience in the use of 
the ZELTIQ CoolSculpting System.  
3.4. 
Site Requirements 
Site investigators should have at least one study coordinator with experience in conducting 
clinical research and with sufficient time to conduct the study. 
3.5. 
Subject Recruitment 
Subjects who seek reduction of fat in the submental area, submandibular area or jowls will 
be recruited from the general population. 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
3.6. 
Sample Size 
A maximum of forty-five (45) subjects will be treated at up to three investigational sites. 
3.7. 
Subject Eligibility 
To be eligible to participate in the study, subjects must meet all of the inclusion criteria 
and none of the exclusion criteria listed in Table 1. 
Table 1.  Eligibility criteria. 
Inclusion Criteria 
a) Male or female subjects > 22 years of age and < 65 years of age. 
b) Treatment area skin fold thickness > 1cm (measured by caliper). 
c) No weight change exceeding 5% of body weight in the preceding month. 
d) Agreement to maintain his/her weight (i.e., within 5%) by not making any 
major changes in diet or exercise routine during the course of the study.  
e) Subject has signed a written informed consent form. 
 
Exclusion Criteria 
a) Excessive skin laxity in the treatment area for which reduction of subcutaneous 
fat may, in the opinion of the investigator, result in an unacceptable aesthetic 
result.  
b) Prominent platysmal bands at rest which may interfere with assessment of 
treatment area. 
c) Evidence of any cause of enlargement in the treatment area other than localized 
subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands. 
d) Significant enlargement on the anterior neck that may prevent the proper 
placement of the applicator e.g. enlarged thyroid glands. 
e) Treatment with dermal fillers, chemical peels, radiofrequency or laser 
procedures that may affect contour in the treatment area within the past 6 
months. 
f) Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the 
treatment area in the past 6 months. 
g) History of facial nerve paresis or paralysis (such as Bell's palsy).  
h) History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, 
etc.) or implant in or adjacent to the area of intended treatment. 
i) History of prior neck surgery, or prior surgery in the area of intended treatment. 
j) Current infection in and adjacent to treatment area. 
k) Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or 
paroxysmal cold hemoglobinuria. 
l) Known history of Raynaud’s disease, or any known condition with a response 
to cold exposure that limits blood flow to the skin.

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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
m) History of bleeding disorder or is taking any medication that in the 
investigator’s opinion may increase the subject’s risk of bruising. 
n) Currently taking or has taken diet pills or weight control supplements within the 
past month. 
o) Any dermatological conditions, such as scars in the location of the treatment 
area that may interfere with the treatment or evaluation. 
p) Active implanted device such as a pacemaker, defibrillator, or drug delivery 
system. 
q) Pregnant or intending to become pregnant in the next 6 months. 
r) Lactating or has been lactating in the past 6 months. 
s) Unable or unwilling to comply with the study requirements. 
t) Currently enrolled in a clinical study of an unapproved investigational drug or 
device. 
u) 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. 
 
 
3.8. 
Informed Consent  
Study candidates shall receive an explanation of the study objectives, possible risks and 
benefits of the study, and be given adequate time to read the information included in the 
informed consent document. Candidates will be given an opportunity to ask questions 
about any of the information contained in the informed consent. Candidates must verbally 
acknowledge understanding of the informed consent, and sign the consent form 
accordingly. This form must have prior approval of the Institutional Review Board (IRB).  
3.9. 
Screening Procedures 
Screening Visit; Required; Day -45 to Day 0 
The subject shall be consented for study participation as described in Section 3.8.  After 
the informed consent is signed, subjects will be screened for eligibility.  Each subject will 
be evaluated to determine that all eligibility criteria are met.  The investigator or designee 
shall complete a brief medical history and examine the subject to confirm eligibility for 
the study. 
 
1. Obtain height and weight 
2. Visually assess and palpate the intended treatment area to determine if it is 
appropriate for treatment. 
3. Measure the skin fold thickness of the intended treatment areas using a caliper. 
4. Assess for dermatological conditions that may lead to exclusion of a subject from 
the study. 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N
 
Protocol Number: ZA17-004 
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. 
5. Document potential candidate’s medication use (including over-the-counter 
medications, vitamins and herbs), Fitzpatrick Skin Type, race and ethnicity as 
well as any skin irregularities (e.g. moles, birth marks, scars, stretch marks, 
discoloration) at the intended treatment area.  
 
All female subjects of childbearing potential will be assessed for the start date of their 
last menstrual cycle to determine if they may be pregnant.  If unsure, a pregnancy test 
(urine) may be taken at the screening visit.  If the subject is pregnant, she will be 
excluded from participation.  Subjects will also 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 subject becomes pregnant during the course of the study, 
she will not be treated subsequently with the study device or be required to have follow-
up photographs or ultrasound measurements taken.   
 
All subjects will be asked to maintain their weight by not making any major changes to 
their diet or exercise regimen during the course of the study.  If a subject’s weight change 
is more than 5% at 12 weeks after the last treatment, the subjects’ data will be excluded 
from the primary effectiveness analyses. Subjects who do not maintain their weight 
within 5% will continue in the study, however their data will be excluded from efficacy 
analyses.   
 
Subjects 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. 
3.10. 
Study Enrollment 
Study Candidates who sign the informed consent, meet eligibility criteria and undergo 
initiation of study treatment are considered enrolled. Study treatment initiation is defined 
as the initiation of the cooling cycle after the placement of the applicator on the intended 
treatment area on the scheduled treatment day. 
3.11. 
Study Photography 
Study candidates who sign the informed consent and meet eligibility criteria will be 
required to have baseline photographs of the intended treatment area taken.  Baseline 
photographs will be taken using a standardized system prior to receiving the first 
treatment, and may also have additional photographs taken at subsequent treatment visits.  
All subjects will return 12 weeks after final treatment to have photographs of the treated 
area taken before exiting the study, using the same system and setup as baseline 
photographs. 

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Part Number: 
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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
3.13.2. 
3-Week Follow-Up Visit; Required: Week3 (± 7 days) 
A phone contact will take place three weeks after each treatment visit to evaluate the 
condition of the treatment area, pain score, and adverse events.  If there are any 
observations reported at the phone follow-up, the subject will be contacted by phone 
weekly until resolution of symptoms is documented.  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 done. Email may be used as an alternate method of 
contact. 
3.13.3. 
6-Week Follow-Up Visit; Required: Week 6 (± 7 days) 
The following evaluations will be performed at the 6-week follow-up visit after 
Treatment Visit #1 and #2. 
 
1. Obtain weight 
2. Perform clinical assessment of the treatment area for any epidermal, 
dermal and subcutaneous findings (e.g., erythema, bruising, swelling, 
pigment changes).   
3. Assess for alterations in sensation (e.g., numbness, tingling).  Assess 
subject pain score using 0 – 10 scale. 
4. Examine the oral cavity for evidence of dry mouth. 
5. Assess lower face motor nerve function.  
6. Assess for any adverse events. 
3.13.4. 
12-Week Final Follow-Up Evaluation; Required (12 weeks ± 14 
days post final treatment)  
The following evaluations will be performed at the 12-week follow-up visit after the 
final treatment visit: 
1. Obtain weight. 
2. Obtain photographs using standardized setup and settings. In addition, 3-
dimensional images may be captured.   
3. Measure fat layer thickness of the treatment area with a commercially-
available ultrasound device using a standardized protocol. 
4. Perform clinical assessment of the treatment areas for any epidermal, 
dermal and subcutaneous findings (e.g., erythema, bruising, swelling, 
pigment changes). 
5. Assess for alterations in sensation (e.g., numbness, tingling).  Assess 
subject pain score using 0 – 10 scale. 
6. Examine the oral cavity for evidence of dry mouth. 
7. Assess lower face motor nerve function.  
8. Assess for any adverse events. 

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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
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Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
9. Administer subject questionnaire to obtain subject feedback on overall 
satisfaction.  
3.13.5. 
Optional Follow-Up Evaluations (up to 4 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. 
Table 2 summarizes study schedule and events at each visit. 
 
 

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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
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ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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 2.  Schedule of Assessments  
  
Post-Treatment Visit #1 
 
Post-Treatment Visit #2 
Screening
(< 1 hr) 
Treatment
Visit #1 
 (<  4 hrs) 
1 Wk 
Follow-Up 
(< 1 hr) 
 
3 Wk 
Follow-Up 
(< 1 hr) 
 
6 Wk Follow-Up 
AND 
Treatment Visit #2 
 (<  4 hrs) 
1 Wk Follow-
Up 
(< 1 hr) 
3 Wk 
Follow-Up 
(< 1 hr) 
 
6 Wk 
Follow-Up  
12 Wk 
Follow-Up  
(< 1 hr) 
Optional **
Follow-Up 
Time Frame
Day - 45 to 0 
Day 0 
Day 7 
(+/- 3 days) 
Day 21 
(+/- 7 days) 
Week 6
(+/- 7 days) 
 
Day 7 
(+/- 3 days) 
Day 21 
(+/- 7 days) 
Week 6 
(+/- 7 days) 
Week 12  
(+/- 14 days) 
Open 
   6 Wk      
Tx #2
Informed Consent*
X
Inclusion/Exclusion Criteria
X
X
X
Pregnancy Test
X
X
X
Medical History
X
Tx Site Assessment
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
Photography
X
X***
X***
X
3-D Photography
X***
X***
X***
X***
Thermal Imaging
X***
X***
Caliper Measurement
X
Ultrasound Measurement
X
X***
X***
X
Treatment
X
X
Pain Assessment
X
X
X
X
X
X
X
X
X
AE Assessment
X
X
X
X
X
X
X
X
X
Subject Survey
X
 
* Informed consent to be signed by subject prior to the collection of any data or completion of any study procedures. 
** Investigator discretion as to timing and extent of follow-up assessment for optional visits. 
*** Optional 

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Part Number: 
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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
 
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. 
 
Serious Adverse Event (SAE) 
 
Any untoward medical occurrence in a subject, regardless of whether the event is related 
to the device that: 
 
a. results in death; 
b. results in a life threatening illness or injury; 
c. results in a permanent impairment of a body structure or body function;  
d. requires in-patient hospitalization or prolongation of existing hospitalization 
e. results in medical or surgical intervention to prevent impairment to body structure or 
function; 
f.    results in fetal distress, fetal death, or a congenital abnormality/birth defect. 
 
Unanticipated Adverse Device Effect (UADE) 
 
Any serious adverse effect on health and safety or any life-threatening problem or death 
caused by, or associated with a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application, or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects.  
 
The Investigator shall be responsible for determination of the causal relationship of all 
adverse events to the device and/or procedure.  The Principal Investigator is responsible 
for monitoring the safety of the subjects enrolled.   
 
The Sponsor is responsible for the ongoing safety evaluation of the product(s). The 
Sponsor shall be responsible for adjudication of all reported adverse events to determine 
whether the event is reportable under federal regulations (i.e., 21 CFR812.150[b][1]). The 
Sponsor will promptly notify all participating investigators and regulatory authorities, as 
appropriate, of findings that could affect adversely the safety of subjects, impact the 
conduct of the trial or alter the IRB’s approval opinion to continue the trial. 
 
3.19. 
Reportable Incidents 
Serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) must be 
reported within 24 hours of knowledge of the event to the Sponsor: 

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Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
IRB Approval 
The investigator may not begin the study until the governing institutional 
review board (IRB) provides 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 subject and that the study is not commenced until IRB 
approval has been obtained.   
Device Accountability 
Device accountability is not applicable for this non-significant risk study.  
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. 
4.3.2. 
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 not 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, 
and a monitor 
 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 subjects 
 Records of each subject's case history, including study-required Case 
Report Forms and source documentation (e.g. physician notes, lab 
reports, study worksheets, clinic charts) 

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ZELTIQ P/N: 
 
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Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
 All relevant observations of adverse device effects 
 Records of any protocol deviations 
 The condition of each subject upon entering and during the course of 
the investigation and any relevant medical history and results of any 
diagnostic tests 
 Record of each subject’s exposure to the device, including the date 
and time of use 
 Investigational plan 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), or the reviewing IRB. 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, subject 
evaluations, study documentation and site monitoring. 
4.3.3. 
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 or violations of the investigational plan shall be 
reported to the Sponsor, and the IRB as required. 
 Failure to obtain informed consent prior to use of a device in a subject 
shall be reported to the Sponsor and IRB within 5 working days after 
the use occurs. 

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Revision: 02
Page 29 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
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. 
4.4. 
Sponsor Responsibilities  
4.4.1. 
General Responsibilities 
As the Sponsor, ZELTIQ assumes overall responsibility for the conduct of 
the study including assurance that the study satisfies FDA regulatory 
requirements. ZELTIQ assumes all responsibilities per applicable 
regulations, and shall: 
IRB approval 
Ensure IRB approval for the investigation. Ensure IRB approval for a 
supplemental application before beginning that portion of the investigation.  
Investigators 
Select investigators qualified by training and experience, and providing them 
with the information they need to conduct the investigation properly.  Obtain 
a signed Investigator Agreement from each participating investigator. Study 
sites will be evaluated to ensure that they have an adequate subject base and 
can provide sufficient staff and documentation support to conduct the study 
properly. 
Monitoring 
Select monitors qualified by training and experience to monitoring the 
study ), and ensure proper monitoring of the investigation. 
Investigational devices 
Not applicable. This is a non-significant risk study 
Data Management and Analysis 
 
Ensure data collection, verification, analysis, records storage, etc. Sponsor  
will assist with presentation(s) and/or publication(s). 
4.4.2. 
Training 
Study Training 
To ensure uniform data collection and protocol compliance, Sponsor 
personnel will provide an educational session to study site personnel as 
needed, which will cover the protocol, techniques for the identification of 
eligible subjects, data collection and form completion, and the device 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 30 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
directions for use.  The investigator and study staff will be trained on the 
study device and protocol, applicable regulations and requirements, and 
expectations of the study, enrollment expectations, subject selection, 
informed consent, required clinical data and record keeping, etc.   
Device Use and Procedure 
 
Representatives of the Sponsor will train study site staff in use of the study 
device.  Sponsor representatives may be present at study procedures. 
4.4.3. 
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, any 
specific recommendations made by the site’s IRB and the signed Investigator 
Agreement.   
Site Qualification Visit 
A pre-study meeting will occur with the study site to evaluate the site’s 
qualification to conduct the study.  
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. 
Monitoring visits will occur at regular intervals. 
During monitoring visits, the monitor will compare subject records and other 
supporting documents with reports at the site to determine that: 
 
Study Site Closeout   
At the close of the study at a clinical site, the monitor will conduct site close 
out per Sponsor’s standard procedure.  

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 31 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
4.4.4. 
Final Report  
A final report will be prepared at the conclusion of the trial. A copy of the 
final report will be provided to each investigator and to the respective IRBs. 
4.4.5. 
Trial Registration  
Prior to study initiation, the trial will be registered on a publicly accessible 
study database such as clinicaltrials.gov when applicable. 
5. Data Ownership 
ZELTIQ, 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.  
6. Publication Policy 
Participating investigators and/or Institutions may publish information or data collected or 
produced as a result of participation in appropriate scientific conference or journals or other 
professional publications subject to written permission from the Sponsor, provided that drafts of 
the material are provided to the Sponsor for purposes of review and comment at least sixty (60) 
days prior to the first submission for publication or public release.  Investigators may not publish 
information regarding site-specific data until a multicenter study report has been published.  
7. Risk/Benefit Analysis 
The Sponsor has undertaken a comprehensive risk-benefit analysis. 
7.1. 
Benefits 
Fat reduction in the treatment area is anticipated to provide an aesthetic benefit and the 
use of this non-invasive system may eliminate the need for an invasive procedure that 
requires anesthesia or recovery time.  Considering the number of surgical procedures 
performed for the removal of fat each year (1.5 million procedures worldwide, according 
to the 2016 International Society of Aesthetic Plastic Surgeons Biennial Global Survey), 
the use of such a non-invasive procedure has the potential to significantly reduce the 
incidence of complications and post-surgical limitations associated with those 
procedures. 
7.2. 
Risks 
Although this study presents minimal risks to the subject, there is the potential for some 
risk when any medical procedure is performed.  

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 32 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N: 
 
Protocol Number: ZA17-004 
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. 
 
Anticipated Device Effects 
 
 
These are known effects of the ZELTIQ Procedure, previously recorded in prior studies 
as transient and/or temporary effects related to the cold application and/or vacuum 
pressure inherent in the treatment. Anticipated effects of the device which will not be 
considered adverse events include:  
 
 inflammation of the subcutaneous fat layer, which is a desired effect of the procedure; 
 sensations of coldness, stinging, burning, pinching, or pressure associated with 
placement of the applicator and the initiation of the cold treatment; 
 known skin effects (e.g., blanching; erythema, bruising, purpura, petechiae, swelling, 
discomfort, tenderness, or soreness at the treatment site, all mild to moderate in 
nature) which are temporary effects that resolve spontaneously shortly after the 
procedure; 
 localized sensory changes (e.g., numbness, tingling) at the treatment area resolving 
within 12 weeks of the procedure; 
 
Adverse Effects 
 
The following summarizes the potential adverse effects in this study: 
 
Potential Adverse Effect
Description
Severe Bruising 
The appearance of ecchymosis (purple colored spots or 
patches > 1cm); purpura (3-4 mm to 1cm); or petechiae 
(pin point red dots, < 3-4 mm) that is rated as severe by the 
investigator; 
Prolonged Bruising
Bruising lasting longer than 1 month
Severe Erythema 
The appearance of erythema (redness) that is rated as 
severe by the investigator 
Prolonged erythema
Erythema lasting longer than 2 weeks.
Severe Swelling 
The appearance of swelling (edema) that is rated as severe 
by the investigator 
Prolonged swelling 
Swelling lasting longer than 1 month. Prolonged swelling 
can lead to sensation of fullness in the back of the throat.
First Degree Burn 
 
A first degree burn is superficial and causes local 
inflammation of the skin. The inflammation is 
characterized by pain, redness, and mild swelling. The skin 
may be very tender to touch.
Second Degree Burn 
Second degree burns are deeper and in addition to the pain, 
redness and inflammation, there is also blistering of the 
skin. 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 02
Page 33 of 33
Title: Non-Invasive Fat Reduction with Cryolipolysis for Jawline Contouring
 
ZELTIQ P/N
 
Protocol Number: ZA17-004 
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. 
Third Degree Burn 
Third degree burns are deeper still, involving all layers of 
the skin.  Because the nerves and blood vessels are 
damaged, third degree burns appear white, leathery and 
tend to be relatively painless.
Cold-induced panniculitis 
Severe inflammation which requires medical or surgical 
intervention
Skin Pigmentary Changes 
The appearance of hyperpigmentation or hypopigmentation 
in the treatment area.
Infection 
Infection at the treatment site, diagnosed by a physician 
and requiring medical intervention.
Discomfort During Procedure 
Discomfort reported during the procedure that is 
intolerable to the subject and results in an interruption or 
discontinuation of the procedure
Discomfort Post Procedure 
Significant discomfort, pain, cramping, tenderness, 
soreness, muscle spasm following the procedure  which 
results in medical intervention (physician visit and/or 
prescription pain reliever)
Prolonged Sensory Alteration 
Post Procedure
Sensory changes (numbness, tingling, burning sensation) 
that are prolonged (i.e., lasting longer than 12 weeks).
Sensory Alteration Requiring 
Medical Intervention
Sensory changes (pain, burning, stinging, hypersensitivity) 
with a severity warranting medical intervention.
Vasovagal Symptoms 
The occurrence of symptoms of anxiety, lightheadedness, 
dizziness, nausea, sweating, near syncope, or syncope 
(fainting).
Motor nerve injury 
Injury to the lower face motor nerves such as marginal 
mandibular nerve (lower lip weakness) or hypoglossal 
nerve (tongue deviation).
Xerostomia  
Injury to the submandibular or parotid gland as evidenced 
by the subjective decrease in saliva production.
Subcutaneous Induration 
Generalized hardness and/or discrete nodules within the 
treatment area, which may develop after the treatment and 
may present with pain and/or discomfort.
Paradoxical Hyperplasia 
Visibly enlarged tissue volume within the treatment area 
that may develop within 2 - 5 months after treatment. 
Surgical intervention may be required.
Contour Irregularity 
Significant indentation or contour irregularity in the 
treatment area that would require surgical correction.
Allergic/Irritant Contact 
Dermatitis
Itchy rashes and skin peeling that may result from 
prolonged exposure to gel or applicator pressure
Other 
Any other untoward medical event determined by the 
investigator to be an adverse event, regardless of the 
relationship to the device or treatment.