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

Model Number	7410-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The removed balloon was returned to obalon for inspection.The balloon was visually inspected as normal and the balloon volume was within specification.The root cause of event is unknown.Per the labeling, 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 or perforation, gastric perforation, 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.
Event or Problem Description
A patient with one balloon administered on (b)(6) 2020 had the balloon removed less than two weeks after administration due to gastric outlet obstruction.The patient began experiencing symptoms of abdominal pain, nausea, and vomiting and presented to the emergency department on (b)(6) 2020 and a ct scan showed a gastric outlet obstruction.The inflated balloon in the stomach was removed endoscopically on (b)(6) 2020.The patient was hospitalized one day and was stable after discharge.The balloon was returned to obalon for investigation.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad, ca
• MDR Report Key: 9821774
• Report Number: 3009256831-2020-00004
• Device Sequence Number: 1568389
• Product Code: LTI
• UDI-Device Identifier: 00859810006234
• UDI-Public: 00859810006234
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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: Health Professional
• Device Expiration Date: 03/24/2020
• Device Model Number: 7410-0001
• Device Lot Number: 190326401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/11/2020
• 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: Hospitalization
• Patient Age: 51 YR
• Patient Weight: 72