Feasibility Study of CoolSculpting Effects on Cellulite Appearance
Phase: NA
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics



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Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
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Protocol Number: ZA20-002 
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Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
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Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
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INVESTIGATOR SIGNATURE PAGE 
 
For protocol number ZA20-002 
 
 
I agree to: 
 
• Implement and conduct this study diligently and in strict compliance with this protocol, GCP, and 
all applicable laws and regulations. 
 
• Maintain all information supplied by the Sponsor, ZELTIQ Aesthetics, an Allergan affiliate, in 
confidence and, when this information is submitted to an Institutional Review Board (IRB) or 
Ethics Committee (EC), or another group, it will be submitted with a designation that the material 
is confidential. 
 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
Investigator printed name 
Signature 
Date 
 
 
 
Investigator printed name 
Signature 
Date 
 
 
 
 
 
 
 
RETURN PAGE TO SPONSOR 

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10.3 
Protocol Adherence .............................................................................................................................. 42 
10.4 
Protocol Amendments .......................................................................................................................... 43 
11 Study Management and Quality Control ......................................................................................... 43 
11.1 
Study Data Collection ........................................................................................................................... 43 
11.2 
Data Management ................................................................................................................................ 44 
11.2.1 
Data Receipt and Data Entry ..........................................................................................................................44 
11.3 
Confidentiality ...................................................................................................................................... 44 
11.4 
Quality Assurance Audits .................................................................................................................... 44 
11.5 
Investigator Responsibilities ................................................................................................................ 45 
11.5.1 
General Responsibilities ................................................................................................................................45 
11.5.2 
Investigator Records ......................................................................................................................................45 
11.5.3 
Investigator Reports .......................................................................................................................................46 
11.6 
Sponsor Responsibilities ....................................................................................................................... 47 
11.6.1 
General Responsibilities: ...............................................................................................................................47 
11.6.2 
Site Monitoring ..............................................................................................................................................48 
11.6.3 
Final Report ...................................................................................................................................................49 
11.6.4 
Trial Registration ...........................................................................................................................................49 
12 Data Ownership ................................................................................................................................ 49 
13 
 ............................................................................................................................ 49 
14 
 ....................................................................................................................... 50 
14.1 
 .................................................................................................................................................. 50 
14.2 
 ...................................................................................................................................................... 50 

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Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
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1. Protocol Summary 
 
Title 
Feasibility study of CoolSculpting Effects on Cellulite Appearance 
Design 
Prospective, open label, interventional feasibility study 
Objective/Purpose 
Evaluate the effects of the CoolSculpting System and applicators for effects 
on the appearance of cellulite in the thigh. 
Enrollment 
Clinical sites 
Up to two hundred (200) subjects 
Up to fifteen (15) investigational sites 
Participant/ 
Subject 
Population 
Treatment: 
Healthy adult women aged 22 – 65 with clearly visible cellulite on their 
thighs that they wish to have reduced. 
Primary 
Endpoints 
Safety endpoint: 
The frequency of device and procedure-related adverse events (AEs), 
including device-related serious adverse events (SADEs) and unanticipated 
adverse events, will be summarized. 
Efficacy endpoint: 
1. Comparison of baseline and 12-week post-final treatment photographs 
to assess visible changes in appearance of the treated areas. 
Sponsor 
ZELTIQ Aesthetics 
4410 Rosewood Dr. 
Pleasanton, CA 94588 

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2. Introduction 
2.1. Background 
Cellulite is a common condition that occurs in a large proportion of the female population. It is a 
benign condition which manifests in lumpy, dimpled flesh on the thighs, hips, buttocks and 
abdomen. Cellulite is a multifactorial disease of the skin, fat, and connective tissues. The 
anatomical structure of the skin/fat layer includes vertical fibers of connective tissue (fibrous 
septa) which tether the skin to subcutaneous fascia. When fat cells enlarge and the dermal layer 
thins and loses elastin, the fat layer bulges, causing the undesirable appearance of dimples and 
waviness. 
ZELTIQ Aesthetics has developed and commercialized cryolipolysis technology for non-invasive 
cold-assisted lipolysis. The CoolSculpting technology is based on the sensitivity of fat cells to 
cold injury in order to selectively eliminate subcutaneous fat tissue. The CoolSculpting System is 
cleared for use in the United States for the indication of cold-assisted lipolysis of the thighs, flank, 
abdomen, submental and submandibular areas, bra fat, back fat, and banana roll; as well as 
temporary reduction of cellulite. 
Mild to moderate improvement in cellulite following the CoolSculpting procedure has been 
reported in the literature.1 The technology reduces subcutaneous fat which minimizes bulging of 
the fat layer and reduces the rippled appearance in the skin. It is thought that controlled cooling 
may stimulate collagen and elastin production in the skin, improving the appearance of cellulite. 
The purpose of this study is to further evaluate the CoolSculpting System for non-invasive 
treatment of cellulite. 
2.2 Regulatory Status 
The CoolSculpting System has been cleared in the United States for use as an aesthetic treatment 
to affect the appearance of the flanks (DEN090002), the abdomen (K120023), the thighs 
(K133212), the submental area (K151179), and bra fat, back fat, and banana roll (K160259). 
Additionally, the System has been cleared for flexible treatment parameter ranges (K142491). 
The device was also previously cleared for cooling as a method to minimize localized pain and 
thermal injury during laser and dermatological treatments under: K060407 (initial clearance), 
K063715 (clearance for warming and massage), K072152 (clearance for flat and belt applicators), 
 
 
1 Carruthers J, Stevens WG, Carruthers A, Humphrey S. Cryolipolysis and skin tightening. Dermatol Surg. 2014 Dec;40 
Suppl 12:S184-9. 

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K080118 (clearance for vacuum applicator), and K090094 (clearance for commercial device). 
This study will investigate the use of the FDA-cleared CoolSculpting System for treatment of 
cellulite in the thigh area. Results from this study will be used in development of future studies 
for an indication approval. 
2.4 Device Description 
The CoolSculpting System is comprised of a control unit (Figure 1), which houses the system 
controller and power source, and a detachable applicator which is used to apply cooling and/or 
warming to the treatment site. The study treatments will be performed using the CoolSculpting 
System with either a surface applicator (Figure 2) or a vacuum applicator (Figure 3), depending 
on applicator conformity and tissue quality of the treatment area. The surface applicator has a flat 
cooling surface that is placed on the treatment area. The vacuum applicator uses vacuum pressure 
to draw tissue into the cup shaped applicator; tissue is then cooled inside the cup in a controlled 
manner. 

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3 Study Objectives 
The objective of this study is to evaluate the effects of the CoolSculpting System and applicators for 
effects on the appearance of cellulite in the thigh. 
 
 
4 
4.1 Study Design 
Up to fifteen sites will enroll up to 200 eligible subjects. Enrollment and follow-up is expected to 
take up to 12 months for each subject. The study duration is expected to be up to 2 years. 
4.2 Investigator Qualifications 
To participate in this study, an investigator must have an active medical license and board 
certification in dermatology and/or plastic surgery. The investigator must undergo training on the 
study device(s) prior to study initiation. 
Site investigators must have at least one study coordinator with experience in conducting aesthetic 
research and with sufficient time to conduct the study. 
4.3 Study Population 
4.3.1 Target Patient Population 
Patients with cellulite on the anterior, lateral or posterior thighs that they wish to 
have reduced will be recruited to participate in this study 

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4.3.2 Subject 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) Female subjects > 22 years of age and < 65 years of age. 
b) Subject has clearly visible cellulite on the intended treatment area (thighs), which in the 
Investigator’s opinion, may benefit from the treatment. 
c) Subject has not had weight change exceeding 5% in the preceding month. 
d) Subject agrees to maintain 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 read and signed a written informed consent form. 
Exclusion Criteria 
a) Subject has had a surgical procedure(s) in the area of intended treatment. 
b) Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the 
area of intended treatment. 
c) Subject has had a non-invasive fat reduction, body contouring, cellulite reduction and/or 
skin tightening procedure in the area of intended treatment within the past 4 months. 
d) Presence of significant suntan in the thighs. 
e) Inability to avoid sun exposure in the thighs. 
f) Subject has a history of hernia in or adjacent to the areas to be treated. 
g) Subject needs to administer or has a known history of subcutaneous injections into the area 
of intended treatment (e.g., heparin, insulin) within the past month. 
h) Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or 
paroxysmal cold hemoglobinuria. 
i) Subject has a known history of Raynaud’s disease, or any known condition with a response 
to cold exposure that limits blood flow to the skin. 
j) Subject has a history of bleeding disorder or is taking any medication that in the 
Investigator’s opinion may increase the subject’s risk of bruising. 
k) Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol. 
l) Subject is taking or has taken diet pills or supplements within the past month. 
m) Subject has any dermatological conditions, such as moderate to excessive skin laxity, or 
scars in the location of the treatment sites, that may interfere with the treatment or 
evaluation (stretch marks is not an exclusion). 
n) Subject has an active implanted device such as a pacemaker, defibrillator, implants (e.g. 
buttock implants), or drug delivery system. 

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4.3.3 Vulnerable Populations 
Children, pregnant women, fetuses, neonates and prisoners are not included in this 
study. 
5 Study Conduct and Procedures 
5.1 
Subject Recruitment 
Study candidates who seek reduction of cellulite in the thighs will be recruited from the general 
population. 
5.2 
Informed Consent 
Subjects will be recruited from the Investigator’s clinical practice and via IRB/EC approved 
advertising. Once the patient’s potential eligibility has been determined, the Investigator or 
designee trained to the protocol will explain the nature and scope of the study, risks and benefits 
of participation, answer questions for the subject, and invite the subject to participate. The study 
will be explained in lay terms. Subjects will be consented for optional skin biopsies prior to study 
enrollment. If the patient agrees to participate, the IRB/EC-approved informed consent will be 
signed and dated by the patient and the Investigator or designee. A copy of the signed and dated 
informed consent will be provided to the study subject. 
o) Subject is pregnant or intending to become pregnant during the study period (in the next 9 
months). 
p) Subject is lactating or has been lactating in the past 6 months. 
q) Subject is unable or unwilling to comply with the study requirements. 
r) Subject is currently enrolled in a clinical study of any other unapproved investigational 
drug or device. 
s) 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. 

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5.3 
Screening Procedures 
5.3.1 Screening Visit; Required; Day -30 to Day 0 
After the informed consent is signed, subjects will be screened for eligibility. Each 
subject will be evaluated to determine that all selection criteria are met. The 
Investigator or designee shall complete a brief medical history and examine the 
subject to confirm eligibility for the study. 
 
Female participants of childbearing potential will be advised to avoid becoming 
pregnant during the study by using a medically accepted form of contraception if 
they are sexually active. If the participant becomes pregnant during the course of the 
study, she will not be treated subsequently with the study device or be required to 
have follow-up photographs taken. Female participants of childbearing potential 
will be assessed for the start date of their last menstrual cycle. 
All participants will be asked to maintain their weight by not making any major 
changes to their diet or exercise routine during the study. Participants who do not 

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maintain their weight within 5% of their baseline body weight will continue in the 
study but will be excluded from the primary effectiveness analyses. 
Participants who meet all inclusion criteria and none of the exclusion criteria shall be 
eligible to participate in the study and the first treatment will be scheduled. 
5.4 

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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 unusual effects (e.g., severe 
discomfort, severe and/or prolonged erythema, bruising, swelling; blistering, etc.) 
which may be related to the study. 

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5.4.2 Follow-up Procedures 
Subjects who receive study treatment with the device will be required to complete all 
follow-up visits and assessments. Subjects are required to undergo follow-up visits 
and assessments after each treatment visit at 1-, 3- and 6-. After completing the final 
treatment subject will complete follow-up assessment at 1-, 3- 6 and 12-Week as 
specified in the protocol. Subjects may also be asked to return for optional 24, and 
36 weeks visits after the final treatment. 
5.4.2.1 
One-Week Post-Treatment Follow-Up; Day 7 ± 3 days 
Clinical site staff will contact (via phone call or email) subjects one week after each 
treatment visit for assessment of the treatment area, pain score, and adverse events. 
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, at the discretion of the Investigator, may be asked to come in for an optional 
visit for appropriate evaluation. 

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Table 3 summarizes the schedule of visits during the Follow-Up Phase of the study 
and the assessments to be performed at each visit. The Follow-Up Phase of the study 
starts after the completion of the final treatment. After the final treatment, a 1 week 
follow up will be conducted remotely, followed by 3-, 6- and 12 -Weeks Follow-Up 
Visits. To study the long-term effect of the treatment, subject may be asked to return 
for 24- and 36-Weeks follow-up (Optional). 

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6 Statistical Methodology and Analyses 
6.1 Primary Endpoints 
The primary endpoints of the study are defined as follows: 
• Safety Endpoint: The frequency of device and procedure-related adverse events (AEs), 
including device-related serious adverse events (SADEs) and unanticipated adverse events, 
will be summarized. 
• Efficacy Endpoint: Comparison of baseline and 12-week post-final treatment photographs 
to assess visible changes in the treated areas. 
6.2 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. 
 
6.3 Analysis Cohorts 
6.3.1 Safety Cohort 
This cohort will consist of all the treated participants with safety evaluation after the 
treatment. This cohort should be identical to the As Treated (AT) cohort. The safety 
data analyses will be performed based on the Safety Cohort. 
6.3.2 Effectiveness Cohorts 
Two groups of subjects will be identified for the analysis of effectiveness endpoints: 
Per Protocol Cohort and the As Treated Cohort. All analyses of effectiveness will be 

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6.3.4 Missing Data Handling 
In general, no imputation for missing data will be made. Data will be analyzed “as- 
is” where subjects with missing data not being included in the analysis. 
6.3.5 Data Pooling 
Data are assumed to be poolable across sites due to: 1) use of the same study 
protocol, 2) equivalent training of all sites in the study protocol and use of the 
investigational device, 3) use of the same CRF at each site, and 4) use of 
Independent Evaluator(s). 
7 Adverse Events 
Adverse events (AE) will be collected and assessed continuously throughout the study. An 
AE is defined in accordance with ISO 14155 as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in study participants, users, or other persons temporally associated with the use of 
study treatment, whether or not considered related to the study treatment. 
Disease signs and symptoms that existed prior to the study treatment are not considered 
AEs unless the condition recurs after the patient has recovered from the pre-existing 
condition or the condition worsens in intensity or frequency during the study. 
Adverse events will be monitored throughout the study beginning with signing of informed 
consent. At each post-baseline visit, the investigator will begin querying for AEs by asking 
each patient a general, non-directed question such as “Have you had any changes to your 
condition since your last visit?” Previous AEs and changes in therapy/concomitant 
medications are to be updated. Directed questioning and examination will then be done as 

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

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d. medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure 
or a body function, or 
e. led to fetal distress, fetal death or a congenital abnormality 
or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, or a 
procedure required by the protocol, without serious deterioration in 
health, is not considered an SAE. 
7.1.4 Time Period and Frequency for Collecting AE and SAE Information 
All AEs and SAEs from the signing of the Informed Consent Form (ICF) until the 
last follow-up visit will be collected at the time points specified in the schedule of 
activities, and as observed or reported spontaneously by study participants. 
Medical occurrences that begin after signing of informed consent and before 
administration of study treatment will be recorded as an AE on the appropriate CRF. 
All SAEs will be recorded and submitted to the Sponsor or designee within 24 hours 
of learning about the event using the SAE form. All non-serious AEs related to the 
devices used in the study, as well as Device Complaints, will be submitted to the 
Sponsor within 7 working days. The investigator will submit any updates on these 
events to the Sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE in former study 
participants. However, if the investigator learns of any SAE, including a death, at 
any time after a participant has completed the final visit of the study, and he/she 
considers the event to be reasonably related to the study treatment or study 
participation, the investigator must promptly report the event to the Sponsor. 
7.1.5 Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open- 
ended and non-leading verbal questioning of the participant is the preferred method 
to inquire about possible AEs. 
7.1.6 Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow 
each participant at subsequent visits/contacts. All SAEs will be followed until 
resolution, stabilization based on investigator’s assessment, the event is otherwise 
explained, the participant is lost to follow-up or until 30 days after completion of the 
study. 
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
Sponsor to elucidate the nature and/or causality of the AE or SAE as fully as 

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possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other health care professionals. 
New or updated information will be recorded in the originally completed CRF. 
The investigator will submit any updated SAE data to the Sponsor 
within 24 hours of receipt of the information. 
7.1.7 Reportable Serious Adverse Events (SAEs) 
Serious adverse events (SAEs and SADEs) as well as unanticipated adverse device 
effects (UADEs) /unanticipated serious adverse device effects (USADE) must be 
reported within 24 hours of knowledge of the event to the Sponsor. 
All adverse events observed by the investigator or reported by the subject will be 
recorded on the appropriate CRF, irrespective of the relationship to the 
investigational device used in the study. Medically significant adverse events will be 
followed until resolved or considered stable at investigator’s discretion. For each 
event, the investigator will record a description, dates of onset and resolution, 
severity, and relationship to the investigational device. The investigator may be 
required to provide follow-up information as-needed to fulfill requirements for 
regulatory reporting. 
Any adverse event that results in withdrawal from the study must be reported to the 
Sponsor after the decision to withdraw the subject is made. 
Any death occurring during the study must be reported to the Sponsor within 24 
hours. 
If an event is classified as an SADE or a UADE/USADE, the Sponsor will determine 
if there is an unreasonable risk to the patients within the study. In the event a 
UADE/USADE is reported during this study, it will be reported to the IRB and to the 
regulatory agencies as appropriate according to the relevant standard operating 
procedures and law of the country where the trial is performed. 
7.1.8 Assessment of Severity 
Severity of adverse events will be determined using the following scale: 
• 
Mild: Event that is easily tolerated and may require only minimal 
treatment or therapeutic intervention. The event does not generally 
interfere with usual activities of daily living. 
• 
Moderate: Events that interfere with usual activities of daily living, 
causing discomfort but poses no significant or permanent risk of 
harm to the research participant. It is usually alleviated with 
additional specific therapeutic intervention. 
• 
Severe: Event that is incapacitating, with inability to work and do 

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the usual activities of daily living, or significantly affects clinical 
status. This may require intensive therapeutic intervention. 
7.1.9 
Assessment of Relatedness 
• 
The investigator is obligated to assess the relationship between study 
treatment and each occurrence of each AE/SAE. 
• 
A reasonable possibility of a relationship conveys that there are facts, 
evidence, and/or arguments to suggest a causal relationship, rather 
than a relationship cannot be ruled out. 
• 
The investigator will use clinical judgment to determine the relatedness. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, 
and other risk factors, as well as the temporal relationship of the event 
to study treatment administration will be considered and investigated. 
• 
The investigator will also consult the investigator’s brochure and/or 
product information, for marketed products, in his/her assessment. 
• 
For each AE/SAE, the investigator must document in the medical notes 
that he/she has reviewed the AE/SAE and has provided an assessment 
of relatedness. 
• 
For each AE/SAE, there are 4 levels of relatedness, as follows: 
• 
Not related 
• 
Possible 
• 
Probable 
• 
Definite relationship 
There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the Sponsor. However, it is 
very important that the investigator always make an assessment of relatedness for 
every event before the initial transmission of the SAE data to the Sponsor. 
• 
The investigator may change his/her opinion of relatedness in light of 
follow-up information and send an SAE follow-up report with the 
updated relatedness assessment. 
• 
The relatedness assessment is one of the criteria used when 
determining regulatory reporting requirements. 

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The investigator will determine the relationship of each adverse event to the study 
device using the question: "Is there a reasonable possibility that the event may be 
related to treatment with the device? Answer 'yes' or 'no' for each adverse event." 
The guideline below should be used to consider relatedness: 
For a “not related” assessment, the adverse event: 
• 
May be judged to be due to extraneous causes such as 
disease or environment or toxic factors 
• 
May be judged to be due to the subject's clinical state or other 
therapy being administered 
• 
Is not biologically plausible 
• 
Does not reappear or worsen when the investigational device is re- 
administered 
• 
Does not follow a temporal sequence from treatment with the 
investigational device, 
For an assessment of relatedness (including, probable and possible 
assessments) there is a reasonable possibility that the event may have 
been caused by the investigational device, the adverse event: 
• 
Follows a temporal sequence from treatment with the device. 
• 
Is a known response to the device based on clinical or 
nonclinical data. 
• 
Could not be explained by the known characteristics of the subject's 
clinical state, environmental or toxic factors, or other therapy 
administered. 
• 
Disappears or decreases upon cessation of the use of the 
device. 
• 
Reappears or worsens when the device is re-administered. 
7.1.10 
Serious Adverse Event Reporting Procedures 
All serious adverse events must be reported to the Sponsor within 24 hours of 
discovery or notification of the event and according to IEC/IRB requirements and 
the institution at which the study is conducted, if applicable. Serious adverse event 
information and any follow-up information will be recorded on a Serious Adverse 
Event Form and transmitted to the Sponsor using the contact information provided 

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by the Sponsor. Note that for each device used in this study, a separate SAE form 
and contact information will be used. The Sponsor is responsible for evaluating and 
reporting any serious adverse event and unexpected serious adverse reactions in 
accordance with all applicable laws and standards. 
Serious Adverse Event Reporting 
Serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) 
must be recorded and reported to the Sponsor or designee within 24 hours of 
knowledge of the event by the clinical study site to the following contact: 
 
 - CoolSculpting 
Fax: 
 
Email: 
 
 
Any additional information regarding the serious adverse event should be submitted 
to the sponsor in a follow-up form within 24 hours of awareness. The Sponsor is 
responsible for regulatory reporting and notifying the IRB, as required. 
Other adverse events, deemed by the Investigator to be non-serious, should be 
provided to the Sponsor as soon as possible and not later than 1 week after knowledge 
of the event. This will be forwarded to the Product Surveillance team within 24 hours 
of receipt by the Sponsor Contact. 
Additional information obtained by the Clinical Site regarding any adverse event, both 
serious and non-serious, will be reported to the Sponsor within 24 hours of awareness. 
Safety Monitoring Considerations 
If an adverse event occurs that in the judgment of the investigator represents a potential 
risk for new subjects, the investigator will contact the Sponsor within 1 working day 
after becoming aware of the event. 
A full reporting of the event shall be provided within 10 working days of the event. 
The Sponsor is then responsible for notifying the IRB/EC, as required. 
 
7.1.11 Pregnancy 
• 
Details of all pregnancies in female participants will be collected 
after the start of study treatment through the duration of the 
pregnancy. 
• 
If a pregnancy is reported, the investigator should inform the 
Sponsor within 24 hours of learning of the pregnancy and the 
Allergan Pregnancy Surveillance Form will be completed. 

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• 
If a female of childbearing potential becomes pregnant during the 
study, the investigator should notify the participant’s physician that 
the participant may have been treated with the investigational device 
and exit the participant from the study. 
• 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal 
death, stillbirth, congenital anomalies, ectopic pregnancy) are 
considered SAEs. 
 
 
8 Device Tracking 
The Sponsor will send the Investigator investigational devices. The Investigator must house study 
devices in an appropriate, secure location. 
The Sponsor will track sending and receiving of devices to/from the Investigator. The Investigator 
must track receipt and final disposition of the devices, and maintain accurate records of the use of 
the device on each study subject. 
In addition, for IDE studies, the Investigator must maintain records of receipt, use and disposition of 
all devices on a device accountability log which will be monitored by the Sponsor and a copy 
collected at the end of the study. An accurate record of the date the device was used on each subject 
must be available for inspection at any time. 
8.1 
Device Packaging and Labeling 
Clinical study devices will be packaged and labeled according to the country’s regulatory 
requirements. 
The study device or its immediate package, will be labeled per the requirements of 21CFR 
812.5(a). 
9 Device Deficiencies and Malfunctions 
A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical device 
with respect to its identity, quality, durability, reliability, safety, or performance.” Device deficiencies 
include malfunctions, use errors, and inadequate labeling. 
If a device deficiency occurs, the investigator will notify the Sponsor. Device deficiencies shall be 
documented throughout the study and appropriately managed and reported to regulatory authorities 
and IRBs as required by national regulations. 

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10 Ethical and Regulatory Considerations 
10.1 
Compliance with Good Clinical Practice 
This study will be conducted in compliance with the principles of the Declaration of Helsinki, 
with the current Good Clinical Practice (GCP) guidelines and with other applicable regulations. 
The Investigator and all study staff will conduct the study in compliance with this protocol. 
Voluntary informed consent will be given by every subject prior to the initiation of any study- 
related procedures. The rights, safety and well-being of the study subjects are the most important 
considerations and prevail over the interests of science and society. All personnel involved in the 
conduct of this study must be qualified by education, training and experience to perform their 
assigned responsibilities. 
10.2 
Institutional Review Board (IRB) and Informed Consent 
Before study initiation, the Investigator must have written and dated approval from the IRB/EC 
for the protocol, consent form, subject recruitment materials/process (e.g., advertisements), and 
any other written information to be provided to subjects. The Investigator should also provide the 
IRB/EC with a copy of the product labeling, information to be provided to subjects and any 
updates. The Investigator will submit documentation of the IRB/EC approval to the Sponsor. 
Copies of all correspondence with the IRB/EC regarding this study must be sent to the Sponsor. 
The IRB/EC-approved consent form must include all elements required by FDA, state, and local 
regulations, and may include appropriate additional elements. 
The Investigator/designee will explain the study to each potential subject and the subject must 
indicate voluntary consent by signing and dating the approved informed consent form. The 
Investigator must provide the subject with a copy of the consent form in a language the subject 
understands. The Investigator will maintain documentation that informed consent was obtained 
prior to the initiation of any study-specific procedures. 
Withdrawal of IRB/EC approval of the Investigator’s part in the investigation must be reported 
to the Sponsor within 5 working days. 
10.3 
Protocol Adherence 
The study investigators are responsible for performing the study in compliance with the protocol. 
Non-adherence to the protocol is to be classified as a protocol violation, protocol deviation, as 
defined below. 
Protocol Violation 
Non-adherence to the protocol that may result in significant additional risk to the participant 
(e.g., enrollment of a participant who does not meet the study criteria). Or, non-adherence to 
Good Clinical Practices (GCP) that may impact patient safety (e.g., failure to obtain proper 

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consent prior to performing study procedures). Violations should be reported to the study 
Sponsor and the IRB within 5 working days if they occur. 
Protocol Deviation 
Non-adherence to study procedures which does not result in additional risk to the participant 
(e.g., participant missed visit). Protocol deviations are not required to be reported to the IRB; 
however, they must be recorded and addressed on the study case report forms and may be 
reported and reviewed in conjunction with the progress report as part of the annual review 
process. 
Protocol Waivers 
Waivers, exceptions or any intentional deviation from the approved protocol are not permitted in 
the study. 
10.4 
Protocol Amendments 
Amendments to the study protocol can be made only by the study Sponsor. A revised protocol 
can be put into place only after governing IRB/EC approval. All administrative letters must be 
submitted to the IRB/EC for their information. 
New or altered consent forms required by the IRB due to a protocol change must be used for any 
subsequent subject enrollment and when the IRB requires, signed by subjects currently enrolled in 
the study. 
11 Study Management and Quality Control 
11.1 
Study Data Collection 
The Sponsor will supply Case Report Forms (CRFs) to all participating sites for this study. 
A CRF is required and will be completed for each included subject. The Investigator has ultimate 
responsibility for the collection and reporting of all data entered on the CRFs and any other data 
collection forms (source documents) and ensuring that they are accurate, authentic/original, 
attributable, complete, consistent, legible, timely (contemporaneous), enduring and available 
when required. The CRFs must be signed by the Investigator to attest that the data contained 
therein are true. 
Paper Based CRFs 
Demographic, Screening (Inclusion/Exclusion), Treatment, Follow Up, Adverse Event, Protocol 
Deviation, and Study Termination Data will be recorded on paper Case Report Forms (CRFs) 
developed by the Sponsor. Completed CRFs will be monitored by the Sponsor or a designee at 

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defined intervals and the original CRFs will be collected. Copies will remain filed at the 
investigational sites. The data will then be reviewed by the Sponsor and entered into a study 
database. Data queries will be issued as necessary to clarify discrepancies. 
11.2 
Data Management 
Data management activities will be performed in accordance with internal Sponsor SOPs for 
handling data in non-significant risk studies conducted under abbreviated IDE requirements. 
11.2.1 Data Receipt and Data Entry 
The monitor will collect clinical study related documents including Case Report Forms 
(CRFs), Data Clarification Forms (DCFs), and any other clinical documents from clinical 
sites and transmit the documents to the Sponsor as appropriate. 
11.3 
Confidentiality 
All information and data concerning study participants will be considered confidential, and 
handled in compliance with all applicable regulations including the requirements of the Health 
Insurance Portability and Accountability Act (HIPAA) of 1996. 
The investigator is responsible for ensuring the confidentiality of subjects throughout the trial. 
A unique identification code will be assigned to each subject participating in this trial. Any data 
that may be published in abstracts, scientific journals, or presented at medical meetings will 
reference a unique subject code and will not reveal the subject’s identity. 
Only authorized site staff, the study Sponsor or the Sponsor’s designee, IRB/EC or regulatory 
authorities will have access to these confidential files. All data used in the analysis, reporting 
and publication of this clinical trial will be maintained without identifiable reference to the 
participant. Any data that may be published in abstracts, scientific journals, or presented at 
medical meetings will reference a unique participant code and will not reveal the participant’s 
identity. 
11.4 
Quality Assurance Audits 
Sponsor representatives or designees may conduct site quality assurance (QA) audits during the 
study. The Investigator must agree to provide the auditor with direct access to all relevant 
documents and discuss any findings with the auditor. 
In the event of an inspection by the FDA or other regulatory authorities, the Investigator must 
give the inspector direct access to relevant documents and to discuss any findings with the 
inspector. The Investigator must notify Sponsor in the event of a FDA site audit. 

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11.5 
Investigator Responsibilities 
11.5.1 General Responsibilities 
Investigators are responsible for ensuring the investigation is conducted according to 
all signed agreements, the Protocol, and applicable FDA regulations. The 
investigator must protect the rights, safety, privacy and welfare of the participants 
under the Investigator’s care. Investigators will assume overall responsibility and 
accountability for study site staff and for the clinical data obtained during the study. 
The investigator assumes all responsibilities per applicable regulations, including but 
not limited to: 
IRB approval: The investigator may not begin the study until the FDA and the 
governing institutional review board (IRB) provide written approval of the study 
protocol and consent form. The investigator is also responsible for fulfilling any 
conditions of approval imposed by the IRB. 
Informed Consent: The investigator must ensure that informed consent is obtained 
from each prospective study participant in accordance with 21 CFR Part 50 and that 
the study is not commenced until FDA and IRB approvals have been obtained. 
Financial Disclosure: Investigators shall provide financial disclosure according to 
federal regulations. 
Study Coordinator: To assure proper execution of the study protocol, each 
investigator must identify a study coordinator for the site who will work with and 
under the authority of the investigator to assure that study requirements are fulfilled 
as appropriate. 
11.5.2 
Investigator Records 
The investigator and study staff must maintain accurate, complete, and current 
records relating to the conduct of the investigation. Records must be retained for a 
period of two years following (1) the date the investigation was completed or 
terminated, or (2) the records are no longer required to support a regulatory 
submission or completion of a product development protocol, whichever is longer. 
Participating investigators shall maintain the following: 
• All correspondence with the Sponsor, another investigator, the IRB, a 
monitor, or the FDA 
• Records of all persons authorized to conduct the study (e.g. Delegation of 
Duties/Signature Authorization, CV) 
• Records of receipt, use or disposition of the device 
• Informed Consent documentation for all enrolled participants 

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Revision: 04 
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Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 
• Records of each participant's case history, including study-required Case 
Report Forms and source documentation (e.g. physician notes, lab reports, 
study worksheets, clinic charts) 
• All relevant observations of adverse device effects 
• Records of any protocol deviations 
• The condition of each participant upon entering and during the course of the 
investigation and any relevant medical history and results of any diagnostic 
tests 
• Record of each participant’s exposure to the device, including the date and 
time of use 
• Protocol with all amendments 
• Current IRB approved informed consent and all previously approved 
versions 
• Signed Investigator Agreement 
• Investigators will be responsible for the accurate and timely completion of 
CRFs during the trial. 
These records must be available and suitable for inspection at any time by Sponsor 
representatives (monitor), the reviewing IRB, or FDA. The Investigator will supply 
access to study-related medical records, original laboratory data, and other records 
and data as they relate to the trial. The investigator will ensure that both he/she and 
his/her study staff have adequate time and resources to devote to the study, including 
study enrollment, participant evaluations, study documentation and site monitoring. 
11.5.3 
Investigator Reports 
The investigator is responsible for preparation and submission of the following 
reports: 
• Report of any unanticipated adverse device effects shall be submitted to the 
Sponsor within 24 hours after the Investigator first learns of the effect 
• Withdrawal of IRB approval of the investigator’s part in the investigation 
shall be reported to the Sponsor within 5 working days 
• Progress reports on the investigation to the sponsor, the monitor, and the 
reviewing IRB annually. Alternatively, the Sponsor may prepare the report. 
• Deviations from the protocol shall be reported to the Sponsor and the IRB 
• Failure to obtain informed consent prior to use of a device in a participant 
shall be reported to the Sponsor and IRB within 5 working days after the use 
occurs 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-307027 
Revision: 04 
Page 47 of 53 
Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 
• 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. 
11.6 
Sponsor Responsibilities 
11.6.1 
General Responsibilities: 
As the Sponsor, ZELTIQ Aesthetics assumes overall responsibility for the conduct 
of the study including assurance that the study satisfies applicable regulatory 
requirements. ZELTIQ Aesthetics assumes all responsibilities per applicable 
regulations, and shall: 
IRB approval: Ensure IRB approval for the investigation. No IDE application is 
necessary for this study. 
Investigators: Select investigators qualified by training and experience, and 
providing them with the information they need to conduct the study properly. 
Obtain a signed Investigator Agreement from each participating investigator. Study 
sites will be evaluated to ensure that they have an adequate participant base and can 
provide sufficient staff and documentation support to conduct the study properly. 
Monitoring: Select monitors qualified by training and experience and ensure proper 
monitoring of the study. 
Data Management and analysis: Ensure data collection, verification, analysis, 
records storage, etc. Sponsor will assist with presentation(s) and/or publication(s). 
Essential Document Records: Maintain all Essential Documents pertaining to the 
study per ISO 14155:2011. Records must be retained for a period of two years 
following (1) the date the investigation was completed or terminated, or (2) the 
records are no longer required to support a regulatory submission or completion of a 
product development protocol, whichever is longer. 
Study Training: To ensure uniform data collection and protocol compliance, 
Sponsor personnel will provide an educational session to study site personnel which 
will cover the Protocol, techniques for the identification of eligible participants, data 
collection and form completion, and the device directions for use. The investigator 
and study staff will be trained on the study device and protocol, applicable 
regulations and requirements, and expectations of the study, enrollment expectations, 
participant selection, informed consent, required clinical data and record keeping, 
etc. 
Device Use: Representatives of the Sponsor will train investigators in use of the 
study device. 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-307027 
Revision: 04 
Page 48 of 53 
Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 
11.6.2 Site Monitoring 
The Sponsor will ensure that qualified clinical monitors are available to monitor and 
oversee the conduct of the trial and that monitoring is performed in accordance with 
the Sponsor’s approved procedures or third-party procedures approved by the 
Sponsor. 
The clinical monitors will evaluate compliance with the protocol and applicable 
regulations, any specific recommendations made by the site’s IRB and the signed 
Investigator Agreement. 
Monitoring Visits 
Monitoring will assess the progress of the clinical study and identify any concerns 
that result from device performance or review of the investigator’s study records, 
study management documents, and informed consent documents. 
Monitoring will ensure continued protocol compliance, accurate data reporting, and 
adequate accounting of shipments of study devices. 
The endpoint of this clinical study involves data captured at the 12-Week follow-up 
visit. Therefore, monitoring will occur after the 12-Week follow-up visits are 
completed at each site. Monitoring will occur at each site prior to study closeout. 
During monitoring visits, the monitor will review participant records and other 
supporting documents to determine that: 
• The facilities used by the investigation continue to be acceptable for the 
purposes of the clinical study 
• Informed consent was properly obtained and documented for all enrolled 
study participants 
• The protocol is being followed, and only eligible participants are being 
enrolled into the study 
• Deviations to the Protocol have been reported to the Sponsor and the IRB, 
as appropriate 
• Adverse events are promptly being reported 
• Device accountability is being maintained 
• Information recorded in the case report forms and study reports are 
accurate, complete, legible and consistent with source documentation 
• Participants failing to complete the clinical study and the reason for failure 
are recorded 
• Missed follow-up visits are noted in the study documentation 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-307027 
Revision: 04 
Page 49 of 53 
Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 
Clinical monitors will provide feedback to the site regarding protocol or study 
compliance. If monitoring reveals significant Investigator noncompliance with the 
study agreements, protocol, applicable regulations, IRB approval conditions, the 
monitor will notify Sponsor Clinical Management. Action will be taken to secure 
compliance, and if further compliance problems persist, or the issue is deemed 
serious (i.e. endangering patient welfare or safety), the site may be removed from the 
study and/or the investigator disqualified from future studies. 
Study Site Closeout 
At the close of the study at an investigational site, the monitor will conduct a final 
visit to ensure that all case report forms have been monitored and retrieved and that 
the investigator’s files are accurate and complete. The monitor will ensure that all 
investigational devices and study supplies are accounted for, and provide for 
appropriate disposition of any remaining supplies. The monitor will review record 
retention requirements with the investigator and any remaining investigator 
obligations are reviewed and ensure that all applicable requirements are met for the 
study. The monitor will prepare a report of the site closeout visit. The closeout visit 
may be combined with a final monitoring visit. 
11.6.3 
Final Report 
A final report will be prepared at the conclusion of the trial. Copies of the final 
report will be provided to each investigator and to the respective IRBs. 
11.6.4 
Trial Registration 
When appropriate, prior to study initiation, the trial will be registered on a publicly 
accessible study database such as clinicaltrials.gov. 
 
 
12 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. 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-307027 
Revision: 04 
Page 50 of 53 
Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 
 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-307027 
Revision: 04 
Page 51 of 53 
Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 
 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-307027 
Revision: 04 
Page 52 of 53 
Title: Feasibility Study of CoolSculpting Effects on Cellulite Appearance 
ZELTIQ P/N: CS-307027-04 
Protocol Number: ZA20-002 
(OneV-83717 v2.0) 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc. Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ.