DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
Phase: NA
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics

Information Cover Page 
 
 
Zeltiq Aesthetics Protocol ZA16-005 
 
DualSculpting the Upper Arms Using Vacuum Applicators and a Customized 
Treatment Approach 
 
 
NCT02939105 
 
Protocol Date: 1 September 2016 
Protocol Redaction Date: 30 November 2020 
 
IRB Approval Date: 9 November 2016 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 01 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
Note: Check with Document Control for current revisions of all referenced documents. 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. 
DUALSCULPTING THE UPPER ARMS USING VACUUM 
APPLICATORS AND A CUSTOMIZED TREATMENT APPROACH  
Investigational Plan 
 
 
Sponsor 
ZELTIQ Aesthetics 
4698 Willow Rd. 
Pleasanton, CA 94588 
Protocol Number: 
ZA16-005 
Protocol Version: 
1.0 
September 1, 2016 
Co-Investigators: 
 
Jason Rivers, MD, FRCPC, DABD, FAAD 
Pacific Dermaesthetics 
1111 West Georgia  
Suite 1790 
Vancouver, BC V6E4M3 
Canada 
 
Sponsor Contacts: 
 
Kerrie Jiang, NP, MSN, CCRP 
Senior Director, Regulatory, Clinical and Medical Affairs 
PH: (925) 621-7462 
Fax: (925) 621-7362 
 
Sponsor: 
 
 
 
 
 
 
 
Print Name and Title 
 
Signature 
 
Date 
 
 
 
 
 
 
 
Investigator: 
 
 
 
 
 
 
 
Print Name and Title 
 
Signature 
 
Date 

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Revision: 01 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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 ..................................................................................................... 4 
2. 
Introduction .............................................................................................................. 5 
2.1. 
Background ................................................................................................................ 5 
2.2. 
Device Description ....................................................................................................... 5 
2.3. 
Regulatory Status ........................................................................................................ 7 
3. 
Study Protocol ........................................................................................................... 7 
3.1. 
Design ......................................................................................................................... 7 
3.2. 
Study Duration ............................................................................................................ 7 
3.3. 
Physician Participants ................................................................................................. 7 
3.4. 
Site Requirements ....................................................................................................... 7 
3.5. 
Subject Recruitment .................................................................................................... 8 
3.6. 
Sample Size ................................................................................................................. 8 
3.7. 
Patient Eligibility......................................................................................................... 8 
3.8. 
Informed Consent........................................................................................................ 9 
3.9. 
Screening Procedures .................................................................................................. 9 
3.9.1. 
Screening Visit; Required; Day -60 to Day 0 ................................................................................ 9 
3.10. 
Enrollment .................................................................................................................10 
3.11. 
Study Treatment ........................................................................................................10 
3.11.1. 
Treatment Visit; Required; Day 0 .......................................................................................... 10 
3.12. 
Follow-up Procedures .................................................................................................12 
3.12.1. 
One-Week Follow-Up Contact; Required: (Day 7 +/- 3 days) .................................................. 12 
3.12.2. 
Four-week Follow-Up Evaluation; Required (Day 28 +/- 7 days) ............................................. 12 
3.12.3. 
Twelve-Week Follow-Up Evaluation; Required (Day 84 +/- 14 days) ...................................... 13 
3.12.4. 
Optional Follow-Up Evaluations (up to 4 within study period) ................................................ 13 
3.13. 
Assessments ...............................................................................................................14 
3.13.1. 
Safety Assessments .............................................................................................................. 14 
3.13.2. 
Photography ........................................................................................................................ 14 
3.13.3. 
Optional Ultrasound Measurement ........................................................................................ 15 
3.13.4. 
Optional Caliper Measurement ............................................................................................. 15 
3.13.5. 
Optional Circumference Measurement ................................................................................... 15 
3.13.6. 
Subject Satisfaction ............................................................................................................. 16 
3.14. 
Endpoints ...................................................................................................................16 
3.14.1. 
Primary Endpoints ............................................................................................................... 16 

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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. 
3.14.2. 
Other Assessments ............................................................................................................... 16 
3.15. 
Statistical Analysis Plan ..............................................................................................16 
3.15.2. 
Analysis Population ............................................................................................................. 16 
3.15.3. 
Endpoint Analysis ............................................................................................................... 17 
3.15.3.1. 
Primary Safety Endpoint:............................................................................................................ 17 
3.15.3.2. 
Primary Efficacy Endpoint: Photographic Evaluation ................................................................. 17 
3.15.3.3. 
Other Assessments: .................................................................................................................... 17 
3.16. 
Protocol Adherence ....................................................................................................18 
3.17. 
Adverse Events ...........................................................................................................18 
3.18. 
Reportable Incidents ..................................................................................................20 
4. 
Study Management and Quality Control .................................................................... 20 
4.1. 
Study Data Collection .................................................................................................20 
4.2. 
Confidentiality ...........................................................................................................20 
4.3. 
Investigator Responsibilities .......................................................................................20 
4.3.1. 
General Responsibilities ........................................................................................................... 20 
4.3.2. 
Investigator Records ................................................................................................................. 21 
4.3.3. 
Investigator Reports ................................................................................................................. 22 
4.4. 
Sponsor Responsibilities .............................................................................................23 
4.4.1. 
General Responsibilities ........................................................................................................... 23 
4.4.2. 
Training .................................................................................................................................. 24 
4.4.3. 
Monitoring .............................................................................................................................. 24 
4.4.4. 
Final Report ............................................................................................................................ 24 
4.4.5. 
Trial Registration ..................................................................................................................... 25 
5. 
Data Ownership ....................................................................................................... 25 
6. 
Publication Policy .................................................................................................... 25 
7. 
Risk/Benefit Analysis ............................................................................................... 25 
7.1. 
Benefits ......................................................................................................................25 
7.2. 
Risks ..........................................................................................................................25 
 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 01 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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 
DualSculpting the Upper Arms Using Vacuum Applicators and a Customized 
Treatment Approach  
Design 
Single-center, prospective, non-randomized, interventional cohort 
Purpose 
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using 
specialized vacuum applicators for non-invasive subcutaneous fat reduction of the 
upper arms. 
Enrollment 
Up to 15 subjects enrolled  
Clinical Sites 
One investigational site 
Subject 
population 
Healthy adult women and men with clearly visible fat on the upper arms that they 
wish to have reduced 
Primary 
Endpoints 
 
Safety endpoint: The primary safety endpoint is the rate of unanticipated 
adverse device effects (UADE). It is expected there will be zero UADEs.  
 
Effectiveness endpoint: Correct identification of pre-treatment vs. 12-week 
post-final treatment images by at least two out of three blinded, independent 
reviewers. Success will be defined as at least 70% correct identification of 
the pre-treatment images.  
 
Additional 
Assessments 
 
Subject satisfaction as assessed by questionnaire administered at 12 weeks 
post-final treatment.   
 
Assessment of fat reduction using various methods, which may include; 
ultrasound, caliper and circumference measurements.   
 
 
Sponsor 
 
ZELTIQ Aesthetics, Inc. 
4698 Willow Rd. 
Pleasanton, CA 94588 
 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 01 
Page 5 of 28 
Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. Introduction  
2.1. 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 pain, 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 to non-invasively 
reduce subcutaneous fat.  The ZELTIQ technology utilizes the sensitivity of fat cells to 
cold injury in order to selectively eliminate subcutaneous fat tissue without affecting the 
skin or other surrounding tissues. Termed cryolipolysis, this technology enables a non-
invasive alternative for subcutaneous fat reduction through cellular apoptosis. 
 
 
 
  
 
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ 
CoolSculpting System using vacuum applicators for non-invasive subcutaneous fat 
reduction in the upper arms.  
vacuum applicators will be used in this 
study to provide a customized treatment approach for each subject’s upper arm 
dimensions. 
 
2.2. Device Description 
The study treatments will be performed using the ZELTIQ CoolSculpting System. 
 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 01 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. 
 
 
 
   
 
This study will evaluate the safety and efficacy of the vacuum applicators to treat the 
upper arms.  The subjects will receive bilateral treatment.  
 At the 
investigator’s discretion, an additional cooling cycle may be delivered to cover the 
treatment area (up to two cycles per each upper arm).     
 
Figure 1:  Cleared ZELTIQ System control unit. 
Figure 2:  Representation of Upper Arm Applicator 

ZELTIQ Aesthetics – Confidential and Proprietary  
 
 
Part Number: 
Revision: 01 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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 (License #78510) 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 five (5) months for each subject. 
3.3. Physician Participants 
Study investigators must be practicing medical physicians with experience in body 
contouring treatments.  
3.4. Site Requirements 
Study investigators must have at least one study coordinator with experience in conducting 
aesthetic research and with sufficient time to conduct the study. 

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Part Number: 
Revision: 01 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. 
3.5. Subject Recruitment 
Subjects who seek reduction of fat in the upper arm will be recruited from the general 
population. 
3.6. Sample Size 
A maximum of fifteen (15) subjects will be treated at one investigational site. 
3.7. Patient Eligibility 
To be eligible to participate, 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) Subject has clearly visible fat sufficient for treatment on the upper arm, which in 
the investigator’s opinion, may benefit from the treatment.  
c) No weight change exceeding 5% in the preceding month. 
d) Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by 
not making any major changes in their diet or exercise routine during the course of 
the study.  
e) Subject has read and signed the study written informed consent form. 
Exclusion Criteria 
a) History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, 
etc.), or implants in or adjacent to the area of intended treatment. 
b) History of prior surgery in the arms. 
c) Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or 
paroxysmal cold hemoglobinuria. 
d) Known history of Raynaud’s disease, or any known condition with a response to 
cold exposure that limits blood flow to the skin. 
e) History of bleeding disorder or is taking any medication that in the investigator’s 
opinion may increase the subject’s risk of bruising. 
f) History of carpal tunnel syndrome, compartment syndrome or deep vein 
thrombosis in the upper extremities. 
g) Currently taking or has taken diet pills or weight control supplements within the 
past month. 
h) Any dermatological conditions, such as scars, infection, in the location of the 
treatment area that may interfere with the treatment or evaluation. 
i) Active implanted device such as a pacemaker, defibrillator, or drug delivery 
system. 
j) Pregnant or intending to become pregnant in the next 5 months. 

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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent 
of ZELTIQ. 
k) Lactating or has been lactating in the past 6 months. 
l) Unable or unwilling to comply with the study requirements. 
m) Currently enrolled in a clinical study of any other unapproved investigational drug 
or device. 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.  
3.9. Screening Procedures 
3.9.1. 
Screening Visit; Required; Day -60 to Day 0 
All subjects screened for the study must be documented on the Screening 
Log. 
 
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. Obtain measurement of upper arm length, distance from peak of bulge to 
elbow, and circumference at peak of bulge. (Optional) 
3. Visually assess and palpate the intended treatment area to determine if it 
is appropriate for treatment. 
4. Assess for dermatological conditions that may lead to exclusion of a 
subject from the study. 
5. Obtain photos of both right and left arms.  (Optional) 
6. Document potential candidate’s medication use (including over-the-
counter medications, vitamins and herbs), Fitzpatrick Skin Type, and 
ethnicity as well as any skin irregularities (e.g. moles, birth marks, scars, 
stretch marks, discoloration) at the intended treatment area.   

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Part Number: 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. 
7. 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 subjects 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 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 and circumference 
taken.  Female subjects of childbearing potential will be assessed for the start 
date of their last menstrual cycle. 
 
All subjects will be asked to maintain their weight by not making any major 
changes to their diet or exercise routine during the course of the study.  If the 
weight change is more than 5% of total body weight at 12 weeks after the 
treatment, the subjects’ data will be excluded from the primary effectiveness 
analyses. Subjects who do not maintain their weight within 5% of total body 
weight 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. 
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 cold therapy after the 
placement of the applicator on the intended treatment area on the scheduled 
treatment day.  
 
3.11. 
Study Treatment 
3.11.1. 
Treatment Visit; Required; Day 0  
1. Review inclusion and exclusion criteria. 
2. Administer pregnancy test for female subjects of childbearing potential 
(urine).  Exclude subject from participation if the results are positive. 

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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
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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. If the subject meets all of the inclusion criteria and none of the exclusion 
criteria, they will be enrolled in the study and proceed with the treatment. 
4. Obtain baseline photographs of both right and left arms using the 
standardized setup and settings. Photos will be taken of each arm from 
the front and the back.  
5. Obtain weight. 
6. Mark the intended treatment areas.  
7. Optional ultrasound measurements of the fat layer in each upper arm may 
be obtained using a standardized ultrasound fat measurement protocol.  
8. Optional caliper measurements of the treatment areas may be obtained.   
9. Optional circumference measurements of the upper arms may be 
obtained.   
10. Determine arm to be treated first based on randomization scheme.  
11. 
 
12. 
 
13. 
14. 
 A securement system may be used to hold 
the applicator in place. 
 
15. 
 
16. The subject’s level of comfort will be assessed during treatment using a 
standard scale of 0-10, 0 being no pain and 10 being worst pain 
imaginable. If discomfort is intolerable, the treatment will be 
discontinued until the subject is comfortable and treatment, at the 
discretion of the investigator, can be resumed.  Discomfort that results in 
either a temporary or permanent cessation of the treatment is to be 
documented as an adverse event. 
17. Assess for sensory/motor alteration (such as numbness, tingling in 
hands/fingers) outside of the treatment area. If present, reposition subject 
and/or applicator.  Reapply applicator as needed.  
18. At the conclusion of the treatment, the investigator or designated staff 
member will examine the treatment site for any epidermal, dermal or 
subcutaneous findings (e.g., blanching, erythema, bruising, swelling); 
alterations in sensation (e.g., numbness, tingling) and pain score will be 
assessed. The subject will be assessed for any sensory alteration outside 
of the treatment area. 
19. 

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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent 
of ZELTIQ. 
 
  
20. At the investigator’s discretion, an additional cooling cycle may be 
delivered to cover the treatment area (up to two cycles per each upper 
arm). For additional cooling cycle, repeat steps 12 through 19.  
21. Repeat steps 11 through 20 on the contralateral arm. Treatments may be 
concurrently on each arm or consecutively.  
 
The need for post-treatment care is not expected for this study.  Subjects 
will be encouraged to call the study site if they experience any 
unexpected effects (e.g., severe discomfort, severe and/or prolonged 
erythema, bruising, swelling; blistering, etc.) which may be related to the 
study. 
 
3.12. 
Follow-up Procedures 
3.12.1. 
One-Week Follow-Up Contact; Required: (Day 7 +/- 3 days)  
Clinical site staff will contact (via phone or email) subjects one week after 
treatment for assessment of the treatment areas, pain score, and adverse 
events. Subjects will be assessed for any sensory alteration outside of the 
treatment areas. If there are any observations reported, the study site should 
obtain a resolution date of the symptoms.  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.  
3.12.2. 
Four-week Follow-Up Evaluation; Required (Day 28 +/- 7 days) 
The following evaluations will be performed at the 4-week follow-up visit: 
 
1. Obtain weight. 
2. Obtain photos of both treated arms using the same standardized setup and 
settings as the pre-treatment photographs (optional).   
3. Perform clinical assessment of the treatment areas.  Evaluate for any 
epidermal, dermal and subcutaneous findings (e.g., erythema, bruising, 
swelling, pigment changes) as well as alterations in sensation (e.g., 
numbness, tingling). Assess for sensory alteration outside of the 
treatment areas.  
4. Assess for adverse events. 
 

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Part Number: 
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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
Protocol Number: ZA16-005 
 
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. 
3.12.3. 
Twelve-Week Follow-Up Evaluation; Required (Day 84 +/- 14 days) 
The following evaluations will be performed at the 12-week visit.  
1. Obtain weight. 
2. Obtain photos of both treated arms using the same standardized setup and 
settings as the pre-treatment photographs.  
3. Optional ultrasound measurements of the fat layer in each upper arm may 
be obtained using a standardized ultrasound fat measurement protocol.    
4.   Optional caliper measurements of the treatment areas may be obtained.  
5.   Optional circumference measurements of the upper arms may be 
obtained.    
6. Perform clinical assessment of each of the treatment areas (right and left 
upper arms). Evaluate for any epidermal, dermal and subcutaneous 
findings (e.g., erythema, bruising, swelling, pigment changes) as well as 
alterations in sensation (e.g., numbness, tingling). Assess for sensory 
alteration outside of the treatment areas. 
7.  Administer subject satisfaction questionnaire. 
8. Assess for adverse events. 
 
3.12.4. 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 3 summarizes study schedule and events at each visit. 
 
 
Table 3.  Study Schedule 
  
Study Task 
Screening 
Visit 
(< 1 hr) 
Treatment  
#1 
(</= 3 hrs) 
1-Week 
Follow-
Up 
(< 1/2 hr) 
4-Week 
Follow-up 
(<1/2 hr) 
12-Week Follow-
up 
(<1 hr) 
Optional 
Follow-
Up* 
Day -60 
to 0 
Day 0 
(+/- 3 
days)  
(+/- 7 
days) 
(+/- 14 days)  
Open 
Informed Consent 
X 
 
 
 
 
 
Eligibility Criteria 
X 
X 
 
 
 
 
Pregnancy Test 
 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Clinical Assessment 
X 
X 
 
X 
X 
 
Height 
X 
 
 
 
 
 
Weight 
X 
X 
 
X 
X 
 

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Title: DualSculpting the Upper Arms Using Vacuum Applicators and a 
Customized Treatment Approach 
 
 
ZELTIQ P/N: 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent 
of ZELTIQ. 
Photography 
X** 
X 
 
X** 
X 
 
Ultrasound (optional) 
 
X 
 
 
X 
 
Caliper Measurement 
(optional) 
 
X 
 
 
X 
 
Circumference Measurement 
(optional) 
 
X 
 
 
X 
 
Treatment 
 
X 
 
 
 
 
Pain Assessment 
 
X 
X 
X 
X 
 
AE Assessment 
 
X 
X 
X 
X 
 
Subject Questionnaire 
 
 
 
 
X 
 
*Investigator discretion as to extent of follow-up assessment for optional visits. 
**Photography is optional at 4-week visit. 
3.13. 
Assessments 
Study-related assessments are described below. 
3.13.1. 
Safety Assessments 
The primary safety endpoint is the rate of device- or procedure-related 
adverse events 12 weeks post-final treatment. Safety will be monitored by 
documentation of adverse events and clinical assessment of the treatment 
sites.  Post-treatment sensory changes outside of treatment areas will also be 
documented and assessed. 
3.13.2. 
Photography 
A series of baseline and follow-up photographs of the treatment areas will be 
taken using standardized set up, lighting, and camera settings to ensure 
consistency.  The subject’s faces will not be on the photographs. No other 
identifiable subject information will be recorded on the photographs. The 
photographs may be cropped or re-sized for comparison purposes but 
otherwise will not be re-touched or altered in any way. Image files will be 
stored electronically by ZELTIQ and indexed by subject identifier. Copies of 
subject photographic data will be filed at the clinical site.  
 
Photos will be reviewed by a blinded independent panel of physician 
reviewers with expertise in the areas of dermatology and/or plastic surgery.  
All photographs will be blinded by removing the subject identification and 
dates of the photographs. The reviewers will be presented with two series of 
photographs for each treatment area, the pre-treatment and the post-treatment 
series, and asked to select the series representing the pre-treatment 
photographs. The order in which the photographs are presented will be 
randomized by subject. The order in which the pre- and post-treatment series 

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are presented will also be randomized. The reviewers will be asked to select 
the baseline photograph series for each treatment area and record their data 
on individual data collection forms provided by the Sponsor. 
 
3.13.3. 
Optional Ultrasound Measurement 
Ultrasound images may be collected pre-treatment and at each specified 
follow-up time point.  The images will be collected by a qualified 
representative of the sponsor or site personnel.  
 
 
 
 Copies of subject-
arm ultrasound data will be filed at the clinical site.  Standardized techniques 
of obtaining images will be used to ensure consistency throughout the study.  
3.13.4. 
Optional Caliper Measurement 
Caliper measurements of the treatment areas may be taken at pre-treatment 
and at 12-weeks post final treatment.  After the treatment area is identified 
and marked, the thickness of fat layer will be measured using a caliper at the 
middle of the fat bulge.  For each treatment area, three (3) measurements will 
be taken and recorded. 
 
  
3.13.5. 
Optional Circumference Measurement 
Circumference data may be collected pre-treatment and at 12-weeks post-
treatment.  
 
 
 
 
  

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3.13.6. 
Subject Satisfaction 
Subject satisfaction data will be collected via a written questionnaire at the 
final 12-week follow-up visit. 
3.14. 
Endpoints 
The objective of this study is to evaluate the safety and efficacy of the CoolSculpting 
System for non-invasive subcutaneous fat reduction in the upper arms.  
3.14.1. 
Primary Endpoints 
The primary endpoints of the study will be defined as follows: 
 Safety endpoint: incidence of device- or procedure-related adverse events 
 Efficacy endpoint: Correct identification of pre-treatment vs. 12-week 
post-final treatment images by two out of three blinded independent 
reviewers. Success will be defined as at least 70% correct identification 
of the pre-treatment images.  
3.14.2. 
Other Assessments 
Additional assessments to be performed in the study are as follows: 
 Subject satisfaction as assessed by questionnaire administered at 12 
weeks post-treatment.   
 Assessment of fat reduction using various methods, which may include; 
ultrasound, caliper and circumference measurements.   
3.15. 
Statistical Analysis Plan 
3.15.1. 
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 error, 
maximum and minimum will be tabulated for continuous data (e.g., age,).  
The significance level will be two-sided 0.05 for all statistical tests. 
3.15.2. 
Analysis Population 
Analysis Populations are defined as following: 
 
Per-protocol Population (PP): 
The Per-protocol Population will consist of all the treated subjects followed 
for 12 weeks and with weight change of no more than five percent of total 

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body weight at the time the 12-week 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. Subjects who do 
not complete treatment on the upper arm will not be included in the efficacy 
analyses. 
 
As-Treated Population (AT): 
This population consists of all treated subjects regardless of weight change, 
etc.   
 
Safety Population (SA): 
This population will consist of all the treated subjects with safety evaluation 
after the treatment.  This population should be identical to the AT population.  
The safety data analyses will be performed based on the Safety Population. 
 
3.15.3. 
Endpoint Analysis 
3.15.3.1. Primary Safety Endpoint: 
The primary safety endpoint is measurement of all device- or procedure-
related adverse events.  All adverse events reported during and following the 
treatment will be included in the safety analysis.   
3.15.3.2. Primary Efficacy Endpoint: Photographic Evaluation 
 
The primary efficacy endpoint is the correct identification of pre- 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.  
 
 
3.15.3.3. Other Assessments: 
 
Subject Satisfaction 
The number and percentage of subjects will be summarized for each possible 
point grade of the satisfaction questionnaire at 12 weeks.  The percentage of 
subjects with satisfied or very satisfied responses will be provided, and the 
corresponding exact 95% confidence interval (per binomial distribution) will 
be calculated.  The percentage and the exact 95% confidence interval of 

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dissatisfied responses (dissatisfied or very dissatisfied) will also be 
calculated. 
 
Other Assessments of Fat Reduction 
Fat reduction may be assessed using other various methods, which may 
include; ultrasound, caliper and circumference measurements.   
3.16. 
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, or protocol exemption, as defined below. 
 
Protocol Violation 
 
Non-adherence to the protocol that may result in significant additional risk to the subject 
(e.g., enrollment of a subject 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 subject 
(e.g., subject missed visit).  Protocol deviations are not required to be reported to the 
IRB; however, they must be recorded 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 Exemption 
 
 
 
  
Exemptions should be reported promptly to the IRB given the severity and circumstances 
of the incident; within 30 days from knowledge of the event is sufficient. 
3.17. 
Adverse Events 
Adverse events (AE) will be assessed continuously throughout the study. An adverse 
event is defined as any untoward medical occurrence in a subject, regardless of whether 
the event is related to the device. 

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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 CFR 812.150[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. 
 

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3.18. 
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: 
Kerrie Jiang 
ZELTIQ Aesthetics 
4698 Willow Rd. 
Pleasanton, CA 94588 
# 650-766-3968 (cell) 
# 925-621-7462 (office) 
# 925-621-7362 (fax) 
 
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. 
4. Study Management and Quality Control  
4.1. Study Data Collection   
Standardized Case Report Forms (CRFs) will be provided to all participating sites.  Data 
will be reviewed by the study monitor and Sponsor data management personnel to 
identify inconsistent or missing data and to ensure compliance with the study protocol. 
4.2. Confidentiality 
All information and data concerning study subjects will be considered confidential, and 
handled in compliance with all applicable regulations including the requirements of the 
Health Information Protection Act (HIPA) of 2004.  
Only authorized site staff, the study Sponsor or the Sponsor’s designee and IRB will have 
access to these confidential files. A unique identification code will be assigned to each 
subject participating in this trial. All data used in the analysis, reporting and publication 
of this clinical trial will be maintained without identifiable reference to the subject. 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. 
4.3. Investigator Responsibilities 
4.3.1. 
General Responsibilities   
Investigators are responsible for ensuring the investigation is conducted 
according to all signed agreements, the Investigational Plan, and applicable 
regulations in their countries. The investigator must protect the rights, safety, 

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privacy and welfare of the subjects 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 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.   
  
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 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, 
and a monitor 
 Records of all persons authorized to conduct the study (e.g. 
Delegation of Duties/Signature Authorization, CV) 

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 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) 
 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 
 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.  

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 Deviations from the investigational plan shall be reported to the 
Sponsor and the IRB. 
 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. 
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 patient base and 
can provide sufficient staff and documentation support to conduct the study 
properly. 
Monitoring 
Select monitors qualified by training and experience to monitor the study and 
ensure proper monitoring of the investigation. 
Investigational devices 
Not applicable. Devices used in this investigation are commercial devices. 
Data Management and Analysis 
 
Ensure data collection, verification, analysis, records storage, etc. Sponsor 
will assist with presentation(s) and/or publication(s). 

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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 to be 
used in the study.  
Device Use 
 
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, applicable 
regulations, 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 
qualifications.  
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. 
Study Site Closeout   
At the close of the study at a clinical site, the monitor may make a final on-
site visit. Closeout monitoring will be conducted per Sponsor’s procedures.  
4.4.4. 
Final Report  
A final report will be prepared at the conclusion of the trial. 

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4.4.5. 
Trial Registration  
Prior to study initiation, the trial will be registered on a publicly accessible 
study database such as clinicaltrials.gov. 
5. 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.  
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 will 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 (1.3 million procedures worldwide, according 
to the 2011 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.  
 
Anticipated Device Effects 
 

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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 bruising (purple discoloration); 
purpura (purple colored spots or patches); or 
petechiae (pin point red dots) that is rated as severe 
by the investigator;  
Prolonged Bruising 
Bruising lasting longer that 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. 
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.  
Third Degree Burn 
Third degree burns are deeper still, involving all 
layers of the skin.  Because the nerves and blood 

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Potential Adverse Effect 
Description 
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 Pigment 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 Alterations 
Post Procedure 
Sensory changes (numbness, tingling, burning 
sensation) that are prolonged (i.e., lasting longer than 
12 weeks). 
Sensory Alterations Requiring 
Medical Intervention 
Sensory changes (pain, burning, stinging, 
hypersensitivity) with a severity warranting medical 
intervention. 
Sensory Alteration Outside 
Treatment Area Post-Treatment 
Sensory or motor nerve alteration (such as numbness 
or tingling in the fingers or hands) that does not 
resolve within twenty minutes following applicator 
removal. 
Vasovagal Symptoms 
The occurrence of symptoms of anxiety, 
lightheadedness, dizziness, nausea, sweating, near 
syncope, or syncope (fainting). 
Nerve injury 
Injury to the arm motor nerves such as ulnar, radial, 
or brachial nerves that innervate the upper and lower 
arm, hand and fingers. 
Contour Irregularity 
Significant indentation or contour irregularity in the 
treatment area that would require surgical 
intervention. 
Allergic/Irritant Contact 
Dermatitis 
Itchy rashes and skin peeling that may result from 
prolonged exposure to gel or gelpad, or applicator 
pressure 
Subcutaneous Indurations 
Hardness within the treatment area, either as general 
firmness or discrete nodules. 

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Potential Adverse Effect 
Description 
Paradoxical Hyperplasia 
Visibly enlarged tissue volume within the treatment 
area which may develop 2-5 months after treatment. 
Surgical intervention may be required. 
Deep Vein Thrombosis 
The occurrence of a blood clot that forms in a vein  
Compartment Syndrome 
Increased pressure within a compartment, such as 
arm or hand, causing pain, tingling or burning 
sensations within the area.  
Other 
Any other untoward medical event determined by the 
investigator to be an adverse event, regardless of the 
relationship to the device or treatment.