Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Exclusion Criteria

• •1. Subject is planning on becoming pregnant during the one year following study device placement
• •2. Subject will complete follow-up visits at a location that the treating physician does not practice
• •3. Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• •4. Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
• •5. Subjects who have conditions that are contraindicated for Orbera365™ IGB System as per the IFU, including, but not limited to:
• •* The presence of more than one IGB at the same time.
• •* Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• •* Potential upper gastrointestinal bleeding conditions
• •* A large hiatal hernia of \> 5cm or a hernia ≤ 5 cm associated with severe or intractable gastro- esophageal reflux symptoms
• •* A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope
• •* Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.
• •* Gastric Mass.
• •* Severe coagulopathy.
• •* Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision.
• •* Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery