MAUDE Adverse Event Report: SUNNYVALE HALO90 ULTRA ABLATION CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	90-9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacture reference number: (b)(4) patient code: (b)(4).(patient experienced stricture with dilation).
Event or Problem Description
According to the reporter, a patient experienced stricture requiring dilation eight weeks after the initial procedure.The patient also experienced pain while swallowing.This was treated with esoxx one and ppi.After the patient received dilation, he was feeling better.Per the account, the device worked properly during the procedure.No other known adverse events were reported.

• Brand Name: HALO90 ULTRA ABLATION CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SUNNYVALE; 540 oakmead parkway; sunnyvale CA 94085
• MDR Report Key: 6101837
• Report Number: 3004904811-2016-00093
• Device Sequence Number: 10836274
• Product Code: GEI
• UDI-Device Identifier: 10884521189379
• UDI-Public: 10884521189379
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2016

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 Model Number: 90-9200
• Device Catalogue Number: 90-9200
• Device Lot Number: F2500555X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2016
• Initial Report FDA Received Date: 11/15/2016
• 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: 76 YR