MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX DEVICE, FG; CRYOSURGICAL UNIT AND ACCESSORIES

Model Number	CFX-1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a uneventful bilateral clarifix procedure on (b)(6) 2020.Patient began to have episodic posterior nose bleeds on (b)(6) 2020.Seen at clinic on (b)(6) 2020.Endoscopy showed no active bleeding, normal tissue changes related to cryotherapy.Seen by local ed on (b)(6) 2020 and on (b)(6) 2020 for packing.Patient went to ed that night with more posterior bleeding.Transferred to another medical center and left side packed.On (b)(6) 2020 visited the operating room.Was noted to have bilateral brisk bleeding from the posterior end of the treatment site bilaterally.Bleeding was controlled with endoscopic monopolar cautery bilaterally.She was kept overnight (b)(6) for observation for additional bleeding and was discharged the am of (b)(6).She has recovered without sequelae or other complications.

• Brand Name: CLARIFIX DEVICE, FG
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• MDR Report Key: 10391136
• Report Number: 3006345872-2020-00004
• Device Sequence Number: 3447207
• Product Code: GEH
• UDI-Device Identifier: 00868438000234
• UDI-Public: 00868438000234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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 Model Number: CFX-1000
• Device Catalogue Number: CFX-0001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/11/2020
• 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: Other
• Patient Age: 70