MAUDE Adverse Event Report: OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM; INTRAGASTIC BALLOON

Model Number	7500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Obalon's labeling addresses the reported event with warnings for monitoring patient's for ulcer symptoms and listing ulcers as a known adverse reaction.Peptic ulcer disease is a known risk and the event has not exceeded the frequency identified in the labeling.
Event or Problem Description
A female patient with three balloons were implanted: first implantation date of (b)(6) 2017, second implantation date of (b)(6) 2017, and third implantation date of (b)(6) 2017, and was prescribed concomitant medication therapy at each balloon placement of protonix and anaspaz for stomach cramps.On (b)(6) 2017, the patient was prescribed carafate additionally for cramping.The patient experienced flu like symptoms on (b)(6) 2017 and the patient took over the counter cough and cold medicine.After the patient's cold, the patient began vomiting intermittently and experienced abdominal burning pain.The patient visited the physician assistant at the prescribing physician's office on approximately (b)(6) 2017 to ensure the symptoms were not as a result of a deflation.All balloons were verified as inflated via c-arm.The patient was prescribed zofran to address nausea and vomiting but nothing was prescribed for the burning and endoscopic visualization was not conducted.The patient began vomiting regularly with constipation and observed stool of black color and foul smell.On (b)(6) 2017, the patient had travelled to another state where the symptoms continued.The patient was admitted to the emergency room where an endoscopy was performed.The three balloons were found fully inflated.They were successfully removed from the patient's stomach without issue.During endoscopy, a few cratered gastric ulcers, one with pigmented material and bleeding, were found on the lesser curvature of the stomach.The largest lesion, which was bleeding was 20 mm in largest the dimension.The area was successfully injected with 5 ml of 1:10,000 solution of epinephrine for hemostasis.Coagulation for hemostasis using bipolar cautery probe was successful and estimated blood loss was minimal.The balloons were discarded by the hospital and therefore not returned to obalon for investigation.The patient was admitted to the hospital and patient was treated with iron supplementation.Per the labeling, patients reporting a loss of fullness, increased hunger, and/or weight gain should be examined by radiograph, as this may be a sign of balloon deflation.Additionally, any increase in nausea, vomiting and/or cramping after initial symptoms have subsided may indicate a deflated balloon.Patients should be evaluated by radiograph and endoscopic visualization might be required if the state of inflation cannot be determined radiographically.Each patient should be monitored closely during the entire device therapy period in order to detect the development of possible complications.Patients should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, esophageal injury, and other possible complications that could occur, and should be advised to contact their physician if these symptoms worsen over time or persist for more than 24 hours.Balloon use requires the concurrent use of proton pump inhibitors for the duration of implantation.Clinical studies have shown that use of 40 mg/day of omeprazole or an equivalent dosage of similar medications is required over the duration of use.Patients must not use gastric irritant medications including but not limited to nsaids or aspirin during use.This can lead to an increase in ulcerations and gastric bleeding events while balloons are in residence.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 6847519
• Report Number: 3009256831-2017-00194
• Device Sequence Number: 1419764
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 7500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 84